ASSERACHROM HPIA TEST KIT— 510(k) K003767

Substantially Equivalent

Diagnostica Stago, Inc.

FDA 510(k) clearance K003767 for ASSERACHROM HPIA TEST KIT, Substantially Equivalent on 2001-02-12. Applicant: Diagnostica Stago, Inc..

Clearance details

Applicant: Diagnostica Stago, Inc.
Product code: Code LCO
Advisory panel: Hematology
Date received: 2000-12-06
Decision date: 2001-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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