ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)— 510(k) K011337

Substantially Equivalent

Accumetrics, Inc.

FDA 510(k) clearance K011337 for ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA), Substantially Equivalent on 2001-10-16. Applicant: Accumetrics, Inc..

Clearance details

Applicant: Accumetrics, Inc.
Product code: Code JOZ
Advisory panel: Hematology
Date received: 2001-05-02
Decision date: 2001-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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