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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 K933682
Device Name DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS
Applicant
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received07/29/1993
Decision Date 04/12/1994
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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