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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
510(k) Number K852391
Device Name EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact BARBARA WARREN
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact BARBARA WARREN
Regulation Number862.1440
Classification Product Code
CFH  
Date Received06/05/1985
Decision Date 10/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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