Fisher Diagnostics
FDA Regulatory Profile
Fisher Diagnostics appears in FDA public data with 4 recalls, 16 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1503-2025, Class II) was initiated on March 6, 2025. Its most recent 510(k) clearance was granted on June 1, 2017.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 16
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1503-2025 | Class II | Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and f | March 6, 2025 |
| Z-1502-2025 | Class II | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and fa | March 6, 2025 |
| Z-2762-2017 | Class II | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 10 | May 19, 2017 |
| Z-2763-2017 | Class II | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; -- | May 19, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Control | June 1, 2017 |
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | September 13, 2007 |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | July 18, 2006 |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | May 10, 2006 |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | January 24, 2005 |
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | August 12, 2004 |
| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | July 21, 2004 |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | December 9, 2002 |
| K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION | February 15, 2002 |
| K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | September 7, 2001 |
| K850160 | FISHER DIAGNOSTICS LATEST-CRP TEST KIT | April 19, 1985 |
| K844346 | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES | March 4, 1985 |
| K844347 | FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT | January 23, 1985 |
| K844047 | FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS | November 9, 1984 |
| K840921 | THERACHEM TDC THERAPEUTIC DRUG CONTROL | April 5, 1984 |
| K833514 | TOXI CHEM SERUM ALCOHOL CONTROL | December 8, 1983 |