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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 K931326
Device Name KING DIAGNOSTICS CK REAGENT
Applicant
KING DIAGNOSTICS, INC.
6856 HAWTHORN PARK DR.
INDIANAPOLIS,  IN  46220
Applicant Contact FRANCES LOH
Correspondent
KING DIAGNOSTICS, INC.
6856 HAWTHORN PARK DR.
INDIANAPOLIS,  IN  46220
Correspondent Contact FRANCES LOH
Regulation Number862.1215
Classification Product Code
CGS  
Date Received03/16/1993
Decision Date 06/15/1993
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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