Simmler, Inc.
FDA Regulatory Profile
Simmler, Inc. has 0 FDA recalls, 3 inspections, 23 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 5, 2025 · NAI
- Latest 510(k)
- Nov 29, 1989
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 23 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 3 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1950226 | Saint Louis, MO | 3 | Aug 5, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | Nov 29, 1989 |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Feb 11, 1988 |
| K874595 | MULTICHEM (R) MAGNESIUM REAGENT | Jan 21, 1988 |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | Jan 7, 1988 |
| K874812 | MULTICHEM CHLORIDE REAGENT S0933 | Dec 18, 1987 |
| K874311 | MULTICHEM (R) TOTAL BILIRUBIN | Nov 25, 1987 |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | Oct 29, 1987 |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | Oct 28, 1987 |
| K873725 | MULTICHEM CREATININE REAGENT S0917 | Oct 20, 1987 |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | Oct 7, 1987 |
| K873697 | MULTICHEM CALCIUM S0910 | Oct 2, 1987 |
| K872010 | MULTICHEM LDH-L REAGENT | Jun 11, 1987 |
| K871975 | MULTICHEM TOTAL PROTEIN REAGENT #S0928 | Jun 5, 1987 |
| K871976 | MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 | Jun 5, 1987 |
| K853244 | TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE | Aug 12, 1985 |
| K853049 | ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE | Aug 2, 1985 |
| K853050 | CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ | Aug 2, 1985 |
| K843938 | LINEAR ENZYMATIC URIC ACID SYSTEM | Oct 30, 1984 |
| K831700 | MULTICHEM ENZYMATIC CHOLESTEROL SYS | Jul 19, 1983 |
| K831398 | LINEAR ENZMATIC URIC ACID SYSTEM | Jun 8, 1983 |