ACCURUN 117 HBEAG POSITIVE CONTROL— 510(k) K972048

Substantially Equivalent

Boston Biomedica, Inc.

FDA 510(k) clearance K972048 for ACCURUN 117 HBEAG POSITIVE CONTROL, Substantially Equivalent on 1997-08-12. Applicant: Boston Biomedica, Inc..

Clearance details

Applicant: Boston Biomedica, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1997-06-02
Decision date: 1997-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Bridgewater, MA, US

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