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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K873399
Device Name TITAN GEL CPK REP SYSTEM
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 Number862.1215
Classification Product Code
JHX  
Date Received08/24/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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