ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL— 510(k) K974809

Substantially Equivalent

Boston Biomedica, Inc.

FDA 510(k) clearance K974809 for ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL, Substantially Equivalent on 1998-02-05. Applicant: Boston Biomedica, Inc..

Clearance details

Applicant: Boston Biomedica, Inc.
Product code: Code LSR
Advisory panel: Microbiology
Date received: 1997-12-23
Decision date: 1998-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Bridgewater, MA, US

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