ENZYGNOST ROTAVIRUS AG— 510(k) K841243

Name: FDA 510(k) clearance K841243
Creator: U.S. Food and Drug Administration
Published: 1984-10-17

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K841243 for ENZYGNOST ROTAVIRUS AG, Substantially Equivalent on 1984-10-17. Applicant: Behring Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1984-03-23
Decision date: 1984-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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