Company ยท US
Sterling Biochemical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1985. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJA | Amyloclastic, Amylase | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| DLI | Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase | 1 |
| JGX | Turbidimetric Method, Triglycerides | 1 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 1 |
| JKF | Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 1985 | K844998 | GLUCOSE(HEXOKINASE) REAGENT SET Sterling Biochemical, Inc. | CFR |
| Jan 8, 1985 | K844251 | ALT/GPT REAGENT SET Sterling Biochemical, Inc. | CKA |
| Sep 14, 1984 | K843332 | ALKALINE PHOSPHATASE REAGENT SET Sterling Biochemical, Inc. | CJE |
| Aug 12, 1984 | K842521 | AST/GOT REAGENT SET UV RATE Sterling Biochemical, Inc. | CIT |
| Jun 14, 1984 | K840064 | UREA NITROGEN REAGENT SET Sterling Biochemical, Inc. | CDQ |
| Feb 4, 1984 | K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT Sterling Biochemical, Inc. | JKF |
| Jan 30, 1984 | K834045 | URIC ACID REAGENT SET Sterling Biochemical, Inc. | KNK |
| Jan 13, 1984 | K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY Sterling Biochemical, Inc. | CJA |
| Nov 25, 1983 | K833062 | SERUM CHOLINESTERASE REAGENT SET Sterling Biochemical, Inc. | DLI |
| Aug 12, 1983 | K831874 | LIPASE REAGENT SET Sterling Biochemical, Inc. | JGX |
| Jun 16, 1983 | K831415 | LACTIC DEHYDROGENASE REAGENT SET Sterling Biochemical, Inc. | CFJ |
| Apr 5, 1983 | K830672 | CREATINE KINASE REAGENT SET Sterling Biochemical, Inc. | JHY |
| Dec 22, 1982 | K823341 | TRIGLYCERIDES REAGENT SET TAG-GK Sterling Biochemical, Inc. | CDT |
| Aug 16, 1982 | K822237 | UREA NITROGEN REAGENT SET (MOD. BERTHEL Sterling Biochemical, Inc. | CDL |
| Apr 26, 1982 | K820950 | TOTAL CHOLESTEROL REAGENT SET Sterling Biochemical, Inc. | CHH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||