CREATINE KINASE REAGENT SET— 510(k) K830672

Name: FDA 510(k) clearance K830672
Creator: U.S. Food and Drug Administration
Published: 1983-04-05

Substantially Equivalent

Sterling Biochemical, Inc.

FDA 510(k) clearance K830672 for CREATINE KINASE REAGENT SET, Substantially Equivalent on 1983-04-05. Applicant: Sterling Biochemical, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Biochemical, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1983-03-04
Decision date: 1983-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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