CROMATEST SYPHILIS DIAGNOSTIC— 510(k) K904496

Substantially Equivalent

Biotrax, Inc.

FDA 510(k) clearance K904496 for CROMATEST SYPHILIS DIAGNOSTIC, Substantially Equivalent on 1991-07-24. Applicant: Biotrax, Inc..

Clearance details

Applicant: Biotrax, Inc.
Product code: Code GMQ
Advisory panel: Microbiology
Date received: 1990-10-02
Decision date: 1991-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

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