RAICHEM(TM) SPIA(TM) IGM REAGENTS— 510(k) K894417

Name: FDA 510(k) clearance K894417
Creator: U.S. Food and Drug Administration
Published: 1989-08-02

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K894417 for RAICHEM(TM) SPIA(TM) IGM REAGENTS, Substantially Equivalent on 1989-08-02. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1989-07-17
Decision date: 1989-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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