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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Analysis, Electrophoretic Hemoglobin
510(k) Number K931465
Device Name REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
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 Number864.7440
Classification Product Code
JBD  
Date Received03/24/1993
Decision Date 07/06/1993
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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