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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A1c Test System
510(k) Number K130255
Device Name HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact JUDITH R WALLACH
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact JUDITH R WALLACH
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Codes
JIT   JJX   LCP  
Date Received02/01/2013
Decision Date 02/28/2014
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
Recalls CDRH Recalls
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