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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Platelet Aggregation
510(k) Number K061991
Device Name PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
Applicant
Helena Laboratories
P.O. Box 752
1530 Lindbergh Dr.
Beaumont,  TX  77704
Applicant Contact PATRICIA FRANKS
Correspondent
Helena Laboratories
P.O. Box 752
1530 Lindbergh Dr.
Beaumont,  TX  77704
Correspondent Contact PATRICIA FRANKS
Regulation Number864.5700
Classification Product Code
GHR  
Date Received07/13/2006
Decision Date 02/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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