CMV BRITE ANTIGENEMIA TEST KIT— 510(k) K951550

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..

Clearance details

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

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