DeviceClearance

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA— 510(k) K061991

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K061991 for PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA, Substantially Equivalent on 2007-02-23. Applicant: Helena Laboratories.

Clearance details

Applicant
Helena Laboratories
Product code
Code GHR
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beaumont, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.