RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)— 510(k) K864992

Name: FDA 510(k) clearance K864992
Creator: U.S. Food and Drug Administration
Published: 1987-02-12

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K864992 for RAICHEM(TM) CREATININE REAGENT (ENZYMATIC), Substantially Equivalent on 1987-02-12. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1986-12-22
Decision date: 1987-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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