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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease, photometric, urea nitrogen
510(k) Number K914903
Device Name QUICKSTART UREA NITROGEN
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 Number862.1770
Classification Product Code
CDN  
Date Received11/01/1991
Decision Date 12/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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