Genchem, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Genchem, Inc.” (first 2004, latest 2009), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 257 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 |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
Review panels
Most recent Genchem, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090283 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 | JIX | 2009-06-05 | 120 |
| K040977 | GENCHEM ELECTROLYTE BUFFER | JGS | 2004-12-27 | 257 |
| K040976 | GENCHEM CREATININE REAGENT | CGX | 2004-12-27 | 257 |
| K040975 | GENCHEM CO2 ACID REAGENT | JFL | 2004-12-27 | 257 |
| K040974 | GLUCOSE OXIDASE, GLUCOSE | CGA | 2004-12-27 | 257 |
| K040973 | BUN REAGENT | CDS | 2004-12-27 | 257 |
| K040972 | CALCIUM, AZO DYE REAGENT | CJY | 2004-12-27 | 257 |
| K040971 | GENCHEM ISE ELECTROLYTE REFERENCE | JGS | 2004-12-22 | 252 |
Recalls
openFDA lists no recalls under a recalling firm named Genchem, 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 Genchem, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Genchem, Inc.” (first 2004, latest 2009), across 7 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 Genchem, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genchem, Inc. is 257 days.
Which FDA product codes appear under Genchem, Inc.?
The most frequent FDA product codes under this applicant name are JGS (Electrode, Ion Specific, Sodium, 2); CDS (Electrode, Ion Specific, Urea Nitrogen, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 8 Genchem, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JGS, Genchem, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.