CMV BRITE ANTIGENEMIA TEST KIT— 510(k) K951550

Name: FDA 510(k) clearance K951550
Creator: U.S. Food and Drug Administration
Published: 1996-01-30

Substantially Equivalent

Biotest Diagnostics Corp.

FDA 510(k) clearance K951550 for CMV BRITE ANTIGENEMIA TEST KIT, Substantially Equivalent on 1996-01-30. Applicant: Biotest Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Biotest Diagnostics Corp.
Product code: Code LIN
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1995-04-04
Decision date: 1996-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denville, NJ, US

Download summary PDF View on FDA.gov ↗

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