VARICELISA, MODIFICATION— 510(k) K943843

Name: FDA 510(k) clearance K943843
Creator: U.S. Food and Drug Administration
Published: 1996-03-14

Substantially Equivalent

Biowhittaker Molecular Applications, Inc.

FDA 510(k) clearance K943843 for VARICELISA, MODIFICATION, Substantially Equivalent on 1996-03-14. Applicant: Biowhittaker Molecular Applications, Inc.. Device class: 2.

Clearance details

Applicant: Biowhittaker Molecular Applications, Inc.
Product code: Code LFY
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1994-07-28
Decision date: 1996-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

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