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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Bleeding Time
510(k) Number K871318
Device Name Q.I.C. BLEEDING TIME DEVICE
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number864.6100
Classification Product Code
JCA  
Date Received04/03/1987
Decision Date 06/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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