Fermco Biochemics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Fermco Biochemics, Inc.” (first 1979, latest 1984), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 | 1 |
| JFS | Coulometric, Chloride | 1 | 1 |
Review panels
Most recent Fermco Biochemics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843832 | TRIGLYCERIDES REAGENT SYSTEM | CDT | 1984-11-27 | 57 |
| K823106 | RERMCO TEST CHLORIDE REAGENT | JFS | 1982-11-16 | 26 |
| K822118 | FERMCOTEST CREATININE TEST REAGENT | CGX | 1982-09-30 | 73 |
| K822117 | FERMCOTEST CO2 REAGNET | JFL | 1982-09-30 | 73 |
| K810567 | GERMCO TEST R GLUCOSE TEST KIT | CGA | 1981-03-13 | 10 |
| K791066 | GLUCOSE GOD-PAP TRINDER METHOD TEST KIT | CGA | 1979-09-04 | 84 |
| K791018 | FERMCOTEST R BUN RATE REAGENT TEST KIT | CDS | 1979-07-17 | 46 |
| K781945 | GLUCOSE OXIDASE REAGENT | CGA | 1979-01-17 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Fermco Biochemics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fermco Biochemics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Fermco Biochemics, Inc.” (first 1979, latest 1984), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fermco Biochemics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fermco Biochemics, Inc. is 57 days.
Which FDA product codes appear under Fermco Biochemics, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 3); CDS (Electrode, Ion Specific, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Next steps
- See all 8 Fermco Biochemics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Fermco Biochemics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.