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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 K893751
Device Name AMYLASE TEST (AML) ITEM NUMBER: 65404
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
JFJ  
Date Received05/19/1989
Decision Date 08/17/1989
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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