Sterling Biochemical, Inc.
Medical device manufacturer in Dearborn, MI.
15510(k) clearances
0PMA approvals
0recalls
Device types
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- CDL Berthelot Indophenol, Urea Nitrogen 1
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
- JHY Colorimetric Method, Cpk Or Isoenzymes 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- JGX Turbidimetric Method, Triglycerides 1
- DLI Acetylcholine Chloride, Specific Reagent… 1
- CJA Amyloclastic, Amylase 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- JKF Dinitrophenyl Hydrazone Measurement… 1
- CDQ Urease And Glutamic Dehydrogenase, Urea… 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- CFR Hexokinase, Glucose 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K844998 | Glucose(Hexokinase) Reagent SetCFR · Traditional | 01/18/1985SE |
| K844251 | Alt/Gpt Reagent SetCKA · Traditional | 01/08/1985SE |
| K843332 | Alkaline Phosphatase Reagent SetCJE · Traditional | 09/14/1984SE |
| K842521 | Ast/Got Reagent Set UV RateCIT · Traditional | 08/12/1984SE |
| K840064 | Urea Nitrogen Reagent SetCDQ · Traditional | 06/14/1984SE |
| K834084 | Hydroxybutyrate Dehydrogenase ReagentJKF · Traditional | 02/04/1984SE |
| K834045 | Uric Acid Reagent SetKNK · Traditional | 01/30/1984SE |
| K833864 | Amylase Reagent Set-Modified CarawayCJA · Traditional | 01/13/1984SE |
| K833062 | Serum Cholinesterase Reagent SetDLI · Traditional | 11/25/1983SE |
| K831874 | Lipase Reagent SetJGX · Traditional | 08/12/1983SE |
| K831415 | Lactic Dehydrogenase Reagent SetCFJ · Traditional | 06/16/1983SE |
| K830672 | Creatine Kinase Reagent SetJHY · Traditional | 04/05/1983SE |
| K823341 | Triglycerides Reagent Set Tag-GkCDT · Traditional | 12/22/1982SE |
| K822237 | Urea Nitrogen Reagent Set (Mod. BerthelCDL · Traditional | 08/16/1982SE |
| K820950 | Total Cholesterol Reagent SetCHH · Traditional | 04/26/1982SE |