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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 K905084
Device Name RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Applicant Contact ALFRED E PEACOCK,JR
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Correspondent Contact ALFRED E PEACOCK,JR
Regulation Number862.1215
Classification Product Code
CGS  
Date Received11/14/1990
Decision Date 12/20/1990
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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