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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K040631
Device Name VITALAB DIRECT BILIRUBIN REAGENT
Applicant
CLINICAL DATA, INC.
1075 WEST LAMBERT ROAD
BREA,  CA  92821 -2944
Applicant Contact WYNN STOCKING
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
JIT  
Date Received03/10/2004
Decision Date 03/18/2004
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 Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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