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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Control, Normal
510(k) Number K941737
Device Name SPECIALTY ASSAYED CONTROL-1
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 Number864.5425
Classification Product Code
GIZ  
Date Received04/07/1994
Decision Date 10/07/1994
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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