Sterling Biochemical, Inc.
Mchenry, IL, US
Sterling Biochemical, Inc. appears in FDA device records in Mchenry, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Sterling Biochemical, Inc. between 1982 and 1985. The busiest year on record is 1984, with 6. The most recent is 1985, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 3 |
| 1983 | 4 |
| 1984 | 6 |
| 1985 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K844998 | GLUCOSE(HEXOKINASE) REAGENT SET | CFR | Substantially Equivalent | |
| K844251 | ALT/GPT REAGENT SET | CKA | Substantially Equivalent | |
| K843332 | ALKALINE PHOSPHATASE REAGENT SET | CJE | Substantially Equivalent | |
| K842521 | AST/GOT REAGENT SET UV RATE | CIT | Substantially Equivalent | |
| K840064 | UREA NITROGEN REAGENT SET | CDQ | Substantially Equivalent | |
| K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | JKF | Substantially Equivalent | |
| K834045 | URIC ACID REAGENT SET | KNK | Substantially Equivalent | |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | CJA | Substantially Equivalent | |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | DLI | Substantially Equivalent | |
| K831874 | LIPASE REAGENT SET | JGX | Substantially Equivalent | |
| K831415 | LACTIC DEHYDROGENASE REAGENT SET | CFJ | Substantially Equivalent | |
| K830672 | CREATINE KINASE REAGENT SET | JHY | Substantially Equivalent | |
| K823341 | TRIGLYCERIDES REAGENT SET TAG-GK | CDT | Substantially Equivalent | |
| K822237 | UREA NITROGEN REAGENT SET (MOD. BERTHEL | CDL | Substantially Equivalent | |
| K820950 | TOTAL CHOLESTEROL REAGENT SET | CHH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- KNKAcid, Uric, Uricase (Colorimetric)
- CJAAmyloclastic, Amylase
- CDLBerthelot Indophenol, Urea Nitrogen
- JHYColorimetric Method, Cpk Or Isoenzymes
- JKFDinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CFRHexokinase, Glucose
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JGXTurbidimetric Method, Triglycerides
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain