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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
510(k) Number K821983
Device Name TITAN GEL LDH ISOENZYME KIT
Applicant
Helena Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Helena Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1445
Classification Product Code
CEX  
Date Received07/06/1982
Decision Date 12/22/1982
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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