RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT— 510(k) K903123

Name: FDA 510(k) clearance K903123
Creator: U.S. Food and Drug Administration
Published: 1990-09-14

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K903123 for RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT, Substantially Equivalent on 1990-09-14. Applicant: Reagents Applications, Inc.. Device class: 1.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code JIQ
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1990-07-16
Decision date: 1990-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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