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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K860135
Device Name EASY-TEST UREA (BUN) REAGENT
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Applicant Contact RAYMOND MILLER
Correspondent
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Correspondent Contact RAYMOND MILLER
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received01/14/1986
Decision Date 02/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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