Biochemical Trade, Inc.: FDA clearances and approvals
Biochemical Trade, Inc. has 20 FDA 510(k) clearances (first 1987, latest 1994), across 19 product codes in 1 review panel. Median 510(k) review time: 35 days.
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 |
|---|---|---|---|
| JHW | U.V. Method, Cpk Isoenzymes | 2 | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (20)
Most recent Biochemical Trade, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | JHW | 1994-11-21 | 151 |
| K910635 | TOTAL BILIRUBIN REAGENT SET | CIG | 1991-05-15 | 92 |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | CEO | 1991-02-27 | 35 |
| K905776 | ALBUMIN REAGENT SET | CJW | 1991-02-26 | 61 |
| K905790 | TOTAL PROTEIN REAGENT SET | CEK | 1991-02-21 | 56 |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | CJE | 1991-02-13 | 57 |
| K905619 | CREATININE (RATE) REAGENT SET | CGX | 1991-02-13 | 61 |
| K905651 | KINETIC AMYLASE DETERMINATION | JFJ | 1991-01-31 | 44 |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | JQB | 1991-01-30 | 43 |
| K905588 | CREATINE KINASE UV REAGENT SET | JHW | 1991-01-17 | 35 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biochemical Trade, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biochemical Trade, Inc. have?
Biochemical Trade, Inc. has 20 FDA 510(k) clearances (first 1987, latest 1994), across 19 product codes in 1 review panel.
How long does FDA take to clear Biochemical Trade, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biochemical Trade, Inc.'s cleared 510(k)s is 35 days.
What devices does Biochemical Trade, Inc. make?
Its most frequent FDA product codes are JHW (U.V. Method, Cpk Isoenzymes, 2); CDL (Berthelot Indophenol, Urea Nitrogen, 1); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1).
Has Biochemical Trade, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biochemical Trade, Inc. Related entities may recall under other names.
Next steps
- See all 20 Biochemical Trade, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHW, Biochemical Trade, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.