ACCURUN 120 HAV IGG POSITIVE CONTROL— 510(k) K971406

Substantially Equivalent

Boston Biomedica, Inc.

FDA 510(k) clearance K971406 for ACCURUN 120 HAV IGG POSITIVE CONTROL, Substantially Equivalent on 1997-08-07. Applicant: Boston Biomedica, Inc..

Clearance details

Applicant: Boston Biomedica, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1997-04-16
Decision date: 1997-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Bridgewater, MA, US

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