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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K033983
Device Name VITALAB IRON REAGENT
Applicant
Clinical Data, Inc.
1075 W. Lambert Rd.
Suite D
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number862.1410
Classification Product Code
JIY  
Date Received12/23/2003
Decision Date 05/21/2004
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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