VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY— 510(k) K896635

Name: FDA 510(k) clearance K896635
Creator: U.S. Food and Drug Administration
Published: 1990-02-02

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K896635 for VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY, Substantially Equivalent on 1990-02-02. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code GNW
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1989-11-22
Decision date: 1990-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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