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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K874302
Device Name QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
Applicant
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Applicant Contact ERNEST S JOHNSON
Correspondent
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Correspondent Contact ERNEST S JOHNSON
Regulation Number862.1660
Classification Product Code
JJT  
Date Received10/20/1987
Decision Date 02/02/1988
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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