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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 K992085
Device Name ABBOTT IMX GLYCATED HEMOGLOBIN II
Applicant
ABBOTT LABORATORIES
DEPT 9YC, BIDG. AP31
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6200
Applicant Contact KATHERINE M WORTLEY
Correspondent
ABBOTT LABORATORIES
DEPT 9YC, BIDG. AP31
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6200
Correspondent Contact KATHERINE M WORTLEY
Regulation Number864.7470
Classification Product Code
LCP  
Date Received06/21/1999
Decision Date 05/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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