PLATELETWORKS— 510(k) K012723

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K012723 for PLATELETWORKS, Substantially Equivalent on 2001-09-28. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JOZ
Advisory panel: Hematology
Date received: 2001-08-15
Decision date: 2001-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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