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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 K861269
Device Name RAICHEM AMYLASE REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Applicant Contact GIOVANNI BUCOLO
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Correspondent Contact GIOVANNI BUCOLO
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received04/04/1986
Decision Date 05/29/1986
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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