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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K855188
Device Name CPK (UV) REAGENT KIT
Applicant
Technostics Intl.
P.O. Box 94090
Washington,  MI  48094
Applicant Contact SUSAN RENEHAN
Correspondent
Technostics Intl.
P.O. Box 94090
Washington,  MI  48094
Correspondent Contact SUSAN RENEHAN
Regulation Number862.1215
Classification Product Code
JHS  
Date Received12/26/1985
Decision Date 03/05/1986
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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