ENZYGNOST TM RUBELLA IGM— 510(k) K813493

Name: FDA 510(k) clearance K813493
Creator: U.S. Food and Drug Administration
Published: 1982-03-04

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K813493 for ENZYGNOST TM RUBELLA IGM, Substantially Equivalent on 1982-03-04. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1981-12-14
Decision date: 1982-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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