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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K936285
Device Name ABBOTT VISION GLYCATED HB, MODIFICATION
Applicant
Abbott Laboratories
Abbott Park,  IL  60064
Applicant Contact Irene Powers
Correspondent
Abbott Laboratories
Abbott Park,  IL  60064
Correspondent Contact Irene Powers
Regulation Number864.7470
Classification Product Code
LCP  
Date Received12/30/1993
Decision Date 06/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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