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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K061014
Device Name ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704 -0752
Applicant Contact PATRICIA FRANKS
Correspondent
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704 -0752
Correspondent Contact PATRICIA FRANKS
Regulation Number864.5425
Classification Product Code
JPA  
Date Received04/13/2006
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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