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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K032458
Device Name ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT
Applicant
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6187
Applicant Contact DENISE FARMER
Correspondent
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6187
Correspondent Contact DENISE FARMER
Regulation Number862.1150
Classification Product Code
JIT  
Date Received08/11/2003
Decision Date 10/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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