RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD— 510(k) K883389

Name: FDA 510(k) clearance K883389
Creator: U.S. Food and Drug Administration
Published: 1988-12-14

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K883389 for RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD, Substantially Equivalent on 1988-12-14. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code JIW
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1988-08-10
Decision date: 1988-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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