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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (U.V.)
510(k) Number K903335
Device Name SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
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 Number862.1775
Classification Product Code
CDO  
Date Received07/25/1990
Decision Date 08/17/1990
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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