Sterling Biochemical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Sterling Biochemical, Inc.” (first 1982, latest 1985), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| 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 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CJA | Amyloclastic, Amylase | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Sterling Biochemical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844998 | GLUCOSE(HEXOKINASE) REAGENT SET | CFR | 1985-01-18 | 23 |
| K844251 | ALT/GPT REAGENT SET | CKA | 1985-01-08 | 67 |
| K843332 | ALKALINE PHOSPHATASE REAGENT SET | CJE | 1984-09-14 | 18 |
| K842521 | AST/GOT REAGENT SET UV RATE | CIT | 1984-08-12 | 46 |
| K840064 | UREA NITROGEN REAGENT SET | CDQ | 1984-06-14 | 157 |
| K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | JKF | 1984-02-04 | 68 |
| K834045 | URIC ACID REAGENT SET | KNK | 1984-01-30 | 68 |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | CJA | 1984-01-13 | 67 |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | DLI | 1983-11-25 | 78 |
| K831874 | LIPASE REAGENT SET | JGX | 1983-08-12 | 60 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sterling Biochemical, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sterling Diagnostics, Inc. (41 510(k)s)
- Sterling Medivations, Inc. (27 510(k)s)
- Sterling Drug, Inc. (9 510(k)s)
- Sterling Diagnostic Imaging, Inc. (7 510(k)s)
- Sterling Medical Devices, Inc. (2 510(k)s)
- Sterling Medical, Inc. (1 510(k)s)
- Sterling Multi-Products, Inc. (1 510(k)s)
- Sterling U.S.A., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterling Biochemical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Sterling Biochemical, Inc.” (first 1982, latest 1985), across 15 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 Sterling Biochemical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterling Biochemical, Inc. is 46 days.
Which FDA product codes appear under Sterling Biochemical, Inc.?
The most frequent FDA product codes under this applicant name are CDL (Berthelot Indophenol, Urea Nitrogen, 1); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Next steps
- See all 15 Sterling Biochemical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDL, Sterling Biochemical, 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.