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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K040976
Device Name GENCHEM CREATININE REAGENT
Applicant
Genchem, Inc.
471 W. Lambert Rd., Suite 107
Brea,  CA  92821
Applicant Contact C.C. ALLAIN
Correspondent
Genchem, Inc.
471 W. Lambert Rd., Suite 107
Brea,  CA  92821
Correspondent Contact C.C. ALLAIN
Regulation Number862.1225
Classification Product Code
CGX  
Date Received04/14/2004
Decision Date 12/27/2004
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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