Medical Device Manufacturer · US , Mchenry , IL

Sterling Biochemical, Inc.

15 submissions · 15 cleared · Since 1982
15
Total
15
Cleared
0
Denied

Sterling Biochemical, Inc. — FDA 510(k) Submissions

Sterling Biochemical, Inc. has submitted 15 FDA 510(k) premarket notifications since 1982, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Amyloclastic, Amylase, Acid, Uric, Uricase (colorimetric), Dinitrophenyl Hydrazone Measurement (colorimetric), Hydroxybutyric Dehydroge, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Enzymatic Esterase--oxidase, Cholesterol . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
GLUCOSE(HEXOKINASE) REAGENT SET
K844998 · CFR Hexokinase, Glucose · Chemistry
Jan 1985 23d
ALT/GPT REAGENT SET
K844251 · CKA Nadh Oxidation/nad... · Chemistry
Jan 1985 67d
ALKALINE PHOSPHATASE REAGENT SET
K843332 · CJE Nitrophenylphosphate,... · Chemistry
Sep 1984 18d
AST/GOT REAGENT SET UV RATE
K842521 · CIT Nadh Oxidation/nad... · Chemistry
Aug 1984 46d
UREA NITROGEN REAGENT SET
K840064 · CDQ Urease And Glutamic... · Chemistry
Jun 1984 157d
HYDROXYBUTYRATE DEHYDROGENASE REAGENT
K834084 · JKF Dinitrophenyl Hydrazone... · Chemistry
Feb 1984 68d
URIC ACID REAGENT SET
K834045 · KNK Acid, Uric, Uricase... · Chemistry
Jan 1984 68d
AMYLASE REAGENT SET-MODIFIED CARAWAY
K833864 · CJA Amyloclastic, Amylase · Chemistry
Jan 1984 67d
SERUM CHOLINESTERASE REAGENT SET
K833062 · DLI Acetylcholine Chloride,... · Chemistry
Nov 1983 78d
LIPASE REAGENT SET
K831874 · JGX Turbidimetric Method,... · Chemistry
Aug 1983 60d
LACTIC DEHYDROGENASE REAGENT SET
K831415 · CFJ Nad Reduction/nadh... · Chemistry
Jun 1983 45d
CREATINE KINASE REAGENT SET
K830672 · JHY Colorimetric Method, Cpk... · Chemistry
Apr 1983 32d
TRIGLYCERIDES REAGENT SET TAG-GK
K823341 · CDT Lipase... · Chemistry
Dec 1982 44d
UREA NITROGEN REAGENT SET (MOD. BERTHEL
K822237 · CDL Berthelot Indophenol,... · Chemistry
Aug 1982 19d
TOTAL CHOLESTEROL REAGENT SET
K820950 · CHH Enzymatic... · Chemistry
Apr 1982 20d
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