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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amyloclastic, Amylase
510(k) Number K843529
Device Name ASTRA SYSTEMS AMYLASE REAGENT KIT
Applicant
Beckman Instruments, Inc.
P.O. Box 3100
Fullerton,  CA  92634
Applicant Contact JACK E SOROKIN
Correspondent
Beckman Instruments, Inc.
P.O. Box 3100
Fullerton,  CA  92634
Correspondent Contact JACK E SOROKIN
Regulation Number862.1070
Classification Product Code
CJA  
Date Received09/07/1984
Decision Date 10/11/1984
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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