Verichem Laboratories, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Verichem Laboratories, Inc.” (first 1988, latest 2012), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 66 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 | 1 | 182 |
| 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 6 | 6 |
| DKB | Calibrators, Drug Mixture | 2 | 2 |
| JIS | Calibrator, Primary | 2 | 2 |
| DNN | Calibrators, Ethyl Alcohol | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
Most recent Verichem Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112834 | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES | JIX | 2012-03-28 | 182 |
| K974290 | MICROPROTEIN STANDARD KIT | JIX | 1997-12-19 | 35 |
| K973345 | MATRIX PLUS MULTI-CALIBRATOR KIT | JIX | 1997-10-29 | 54 |
| K972333 | AMMONIA/IRON STANDARD KIT | JIX | 1997-07-23 | 30 |
| K924904 | HDL-CHOLESTEROL STANDARD, MODIFICATION | JIS | 1993-01-13 | 106 |
| K912513 | ELECTROLYTE CONTROL | JJR | 1991-07-19 | 43 |
| K901113 | MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD | JIS | 1990-03-29 | 22 |
| K882059 | BILIRUBIN STANDARD | JIT | 1988-10-25 | 162 |
| K881320 | URINE TOXICOLOGY STANDARD | DKB | 1988-09-09 | 165 |
| K875285 | MULTI-CHEMISTRY LINEARITY STANDARD | JIX | 1988-09-02 | 248 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Verichem Laboratories, 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 Verichem Laboratories, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Verichem Laboratories, Inc.” (first 1988, latest 2012), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Verichem Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Verichem Laboratories, Inc. is 66 days.
Which FDA product codes appear under Verichem Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 6); DKB (Calibrators, Drug Mixture, 2); JIS (Calibrator, Primary, 2).
Next steps
- See all 14 Verichem Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIX, Verichem Laboratories, 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.