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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K905661
Device Name SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
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 Number862.1635
Classification Product Code
CEK  
Date Received12/18/1990
Decision Date 01/31/1991
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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