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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K011843
Device Name GENZYME DIRECT-AMYLASE TEST REAGENT
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 Number862.1070
Classification Product Code
JFJ  
Date Received06/12/2001
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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