RAICHEM(TM) CREATINE KINASE-MB REAGENT— 510(k) K913398

Name: FDA 510(k) clearance K913398
Creator: U.S. Food and Drug Administration
Published: 1991-09-25

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K913398 for RAICHEM(TM) CREATINE KINASE-MB REAGENT, Substantially Equivalent on 1991-09-25. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1991-07-30
Decision date: 1991-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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