RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)— 510(k) K880576

Name: FDA 510(k) clearance K880576
Creator: U.S. Food and Drug Administration
Published: 1988-06-10

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K880576 for RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID), Substantially Equivalent on 1988-06-10. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1988-02-10
Decision date: 1988-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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