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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saccharogenic, Amylase
510(k) Number K873250
Device Name ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
Applicant
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109 -3597
Applicant Contact ADRIENNE CHOMA
Correspondent
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109 -3597
Correspondent Contact ADRIENNE CHOMA
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received08/17/1987
Decision Date 10/20/1987
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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