P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN— 510(k) K905385

Name: FDA 510(k) clearance K905385
Creator: U.S. Food and Drug Administration
Published: 1991-03-21

Substantially Equivalent

Virion (U.S.), Inc.

FDA 510(k) clearance K905385 for P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN, Substantially Equivalent on 1991-03-21. Applicant: Virion (U.S.), Inc.. Device class: 1.

Clearance details

Applicant: Virion (U.S.), Inc.
Product code: Code GQS
Device class: Class 1
Regulation: 21 CFR 866.3400
Advisory panel: Microbiology
Date received: 1990-11-30
Decision date: 1991-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

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