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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Starch-Dye Bound Polymer, Amylase
510(k) Number K884382
Device Name AMYLASE TEST (AMYL) ITEM NUMBER: 65653
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact ANNA G BENTLEY
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact ANNA G BENTLEY
Regulation Number862.1070
Classification Product Code
CIW  
Date Received10/18/1988
Decision Date 01/11/1989
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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