RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV— 510(k) K905084

Name: FDA 510(k) clearance K905084
Creator: U.S. Food and Drug Administration
Published: 1990-12-20

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K905084 for RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV, Substantially Equivalent on 1990-12-20. 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: 1990-11-14
Decision date: 1990-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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