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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K920147
Device Name THROMBIN CLOTTING TIME REAGENT
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 Number864.7875
Classification Product Code
GJA  
Date Received01/13/1992
Decision Date 05/01/1992
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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