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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name O-Phthalaldehyde, Urea Nitrogen
510(k) Number K840213
Device Name BLOOD UREA NITROGEN REAGENT SYS
Applicant
Sclavo, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sclavo, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1770
Classification Product Code
JGZ  
Date Received01/19/1984
Decision Date 03/19/1984
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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