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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 K980013
Device Name AMYLASE
Applicant
Ac Biochemicals, Inc.
17955 Sky Park Circle, Suite J
Irvine,  CA  92614
Applicant Contact CHARLES C ALLAIN
Correspondent
Ac Biochemicals, Inc.
17955 Sky Park Circle, Suite J
Irvine,  CA  92614
Correspondent Contact CHARLES C ALLAIN
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received01/02/1998
Decision Date 02/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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