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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrophoretic, lactate dehydrogenase isoenzymes
510(k) Number K874145
Device Name TITAN GEL REP LDH-6 HV
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Applicant Contact ERIC PETERSEN
Correspondent
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Correspondent Contact ERIC PETERSEN
Regulation Number862.1445
Classification Product Code
CFE  
Date Received10/13/1987
Decision Date 11/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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