MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN— 510(k) K905306

Name: FDA 510(k) clearance K905306
Creator: U.S. Food and Drug Administration
Published: 1991-06-17

Substantially Equivalent

Virion (U.S.), Inc.

FDA 510(k) clearance K905306 for MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN, Substantially Equivalent on 1991-06-17. Applicant: Virion (U.S.), Inc.. Device class: 1.

Clearance details

Applicant: Virion (U.S.), Inc.
Product code: Code GRC
Device class: Class 1
Regulation: 21 CFR 866.3380
Advisory panel: Microbiology
Date received: 1990-11-28
Decision date: 1991-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

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