RAICHEM(TM) SPIA(TM) IGG REAGENTS— 510(k) K894416

Name: FDA 510(k) clearance K894416
Creator: U.S. Food and Drug Administration
Published: 1989-08-01

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K894416 for RAICHEM(TM) SPIA(TM) IGG REAGENTS, Substantially Equivalent on 1989-08-01. Applicant: Reagents Applications, Inc.. Device class: 1.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code KTO
Device class: Class 1
Regulation: 21 CFR 866.5530
Advisory panel: Immunology
Date received: 1989-07-17
Decision date: 1989-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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