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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 K921057
Device Name AMYLASE REAGENT
Applicant
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Applicant Contact RUSSELL H HERNDON
Correspondent
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Correspondent Contact RUSSELL H HERNDON
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received03/05/1992
Decision Date 03/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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