ENZYGNOST ANTIHERPES SIMPLEX VIRUS— 510(k) K841245

Name: FDA 510(k) clearance K841245
Creator: U.S. Food and Drug Administration
Published: 1985-11-05

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K841245 for ENZYGNOST ANTIHERPES SIMPLEX VIRUS, Substantially Equivalent on 1985-11-05. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1984-03-23
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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