SPECTROLYSE PAI-1, MODEL 101201— 510(k) K063323

Substantially Equivalent

American Diagnostica, Inc.

FDA 510(k) clearance K063323 for SPECTROLYSE PAI-1, MODEL 101201, Substantially Equivalent on 2007-08-15. Applicant: American Diagnostica, Inc..

Clearance details

Applicant: American Diagnostica, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 2006-11-03
Decision date: 2007-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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