COXSACKIE VIRUS B1-B6 CF ANTIGENS— 510(k) K921618

Name: FDA 510(k) clearance K921618
Creator: U.S. Food and Drug Administration
Published: 1992-06-29

Substantially Equivalent

Virion (U.S.), Inc.

FDA 510(k) clearance K921618 for COXSACKIE VIRUS B1-B6 CF ANTIGENS, Substantially Equivalent on 1992-06-29. Applicant: Virion (U.S.), Inc.. Device class: 1.

Clearance details

Applicant: Virion (U.S.), Inc.
Product code: Code GNG
Device class: Class 1
Regulation: 21 CFR 866.3145
Advisory panel: Microbiology
Date received: 1992-04-06
Decision date: 1992-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

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