VZV BIO-ENZABEAD SCREEN KIT— 510(k) K833637

Name: FDA 510(k) clearance K833637
Creator: U.S. Food and Drug Administration
Published: 1984-02-10

Substantially Equivalent

Bionetic Laboratory Products

FDA 510(k) clearance K833637 for VZV BIO-ENZABEAD SCREEN KIT, Substantially Equivalent on 1984-02-10. Applicant: Bionetic Laboratory Products. Device class: 2.

Clearance details

Applicant: Bionetic Laboratory Products
Product code: Code LFY
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1983-10-17
Decision date: 1984-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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