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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 K810853
Device Name CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT
Applicant
The Upjohn Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Upjohn Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1215
Classification Product Code
CGS  
Date Received03/30/1981
Decision Date 05/29/1981
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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