IS BORRELIA BURGDORFERI IGM TEST SYSTEM— 510(k) K983606

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K983606 for IS BORRELIA BURGDORFERI IGM TEST SYSTEM, Substantially Equivalent on 1998-12-16. Applicant: Columbia Bioscience, Inc..

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code LSR
Advisory panel: Microbiology
Date received: 1998-10-14
Decision date: 1998-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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