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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 K000239
Device Name GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
Applicant
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE,  MA  02142 -1562
Applicant Contact BARBARA PIZZA
Correspondent
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE,  MA  02142 -1562
Correspondent Contact BARBARA PIZZA
Regulation Number864.7470
Classification Product Code
LCP  
Date Received01/27/2000
Decision Date 03/21/2000
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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