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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 K770750
Device Name REAGENT KIT, ENZYMATIC AMYLASE
Applicant
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received04/25/1977
Decision Date 07/05/1977
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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