HYDROXYBUTYRATE DEHYDROGENASE REAGENT— 510(k) K834084

Name: FDA 510(k) clearance K834084
Creator: U.S. Food and Drug Administration
Published: 1984-02-04

Substantially Equivalent

Sterling Biochemical, Inc.

FDA 510(k) clearance K834084 for HYDROXYBUTYRATE DEHYDROGENASE REAGENT, Substantially Equivalent on 1984-02-04. Applicant: Sterling Biochemical, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Biochemical, Inc.
Product code: Code JKF
Device class: Class 1
Regulation: 21 CFR 862.1380
Advisory panel: Clinical Chemistry
Date received: 1983-11-28
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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