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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 K812341
Device Name UREA NITROGEN (BUN)
Applicant
POINTE SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
POINTE SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received08/18/1981
Decision Date 09/01/1981
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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