PLATELETWORKS, MODELS PW-A, PW-C— 510(k) K023761

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K023761 for PLATELETWORKS, MODELS PW-A, PW-C, Substantially Equivalent on 2003-02-14. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JOZ
Advisory panel: Hematology
Date received: 2002-11-08
Decision date: 2003-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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