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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 K030528
Device Name ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
Applicant
Clinical Data
1075 W. Lambert Rd.
Suite D
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Clinical Data
1075 W. Lambert Rd.
Suite D
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1410
Classification Product Code
JIY  
Subsequent Product Code
JMO  
Date Received02/19/2003
Decision Date 06/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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