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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 K983726
Device Name GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
Applicant
Genzyme Corp.
500 Kendall St.
Cambridge,  MA  02142 -1562
Applicant Contact BARBARA PIZZA
Correspondent
Genzyme Corp.
500 Kendall St.
Cambridge,  MA  02142 -1562
Correspondent Contact BARBARA PIZZA
Regulation Number864.7470
Classification Product Code
LCP  
Date Received10/22/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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