AMNIO STAT-FLM AGGLUTINATION TEST— 510(k) K834616

Substantially Equivalent

Hana Biologics, Inc.

FDA 510(k) clearance K834616 for AMNIO STAT-FLM AGGLUTINATION TEST, Substantially Equivalent on 1984-05-25. Applicant: Hana Biologics, Inc..

Clearance details

Applicant
Hana Biologics, Inc.
Product code
Code JHG
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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