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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diacetyl-Monoxime, Urea Nitrogen
510(k) Number K781305
Device Name UREA NITROGEN
Applicant
ANALYTICAL & RESEARCH CHEMICALS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ANALYTICAL & RESEARCH CHEMICALS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDW  
Date Received07/28/1978
Decision Date 08/31/1978
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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