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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K040972
Device Name CALCIUM, AZO DYE 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 Number862.1145
Classification Product Code
CJY  
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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