RAICHEM CO2 REAGENT— 510(k) K854544

Name: FDA 510(k) clearance K854544
Creator: U.S. Food and Drug Administration
Published: 1985-12-13

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K854544 for RAICHEM CO2 REAGENT, Substantially Equivalent on 1985-12-13. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1985-11-13
Decision date: 1985-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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