Sigma Diagnostics, Inc. FDA Record
- Latest inspection NAI · Jan 11, 2018
- No warning letters matched by name
Sigma Diagnostics, Inc. has 0 FDA recalls, 1 inspection, 164 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sigma Diagnostics, Inc." is on file.
- Latest inspection
- Jan 11, 2018 · NAI
- Latest 510(k)
- Aug 30, 2002
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 164 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Sigma Diagnostics, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Sigma Diagnostics, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 11, 2018 | Livonia, MI | Devices | No Action Indicated (NAI) | 3011189186 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011189186 | Livonia, MI | 1 | Jan 11, 2018 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION… | Aug 30, 2002 |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Feb 6, 2002 |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | Dec 26, 2001 |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | Nov 15, 2001 |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | Nov 15, 2001 |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | Oct 26, 2001 |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | Mar 30, 2001 |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | Mar 22, 2001 |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | Mar 15, 2001 |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Mar 1, 2001 |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | Mar 1, 2001 |
| K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P | Aug 10, 2000 |
| K993741 | EZ LDL CHOLESTEROL TEST SYSTEM | Jul 3, 2000 |
| K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | Jun 26, 2000 |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Apr 7, 2000 |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Apr 7, 2000 |
| K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 | Dec 6, 1999 |
| K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 | Dec 6, 1999 |
| K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT… | Sep 28, 1999 |
| K992798 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20… | Sep 28, 1999 |
Sigma Diagnostics, Inc. and the FDA: common questions
Has Sigma Diagnostics, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Sigma Diagnostics, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Sigma Diagnostics, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Sigma Diagnostics, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sigma Diagnostics, Inc.?
The most recent FDA inspection on file ended Jan 11, 2018 at Livonia, MI and was classified NAI. FDA has 1 inspection of Sigma Diagnostics, Inc. on file.
Need more than this page shows? Ask about Sigma Diagnostics, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.