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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
510(k) Number K191296
Device Name Pointe Scientific Creatinine Kinase (CK) Reagent Set
Applicant
Medtest DX
5449 Research Dr.
Lincoln Park,  MI  48188
Applicant Contact William Cripps
Correspondent
Medtest DX
5449 Research Dr.
Lincoln Park,  MI  48188
Correspondent Contact William Cripps
Regulation Number862.1215
Classification Product Code
CGS  
Date Received05/14/2019
Decision Date 08/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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