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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name berthelot indophenol, urea nitrogen
510(k) Number K792417
Device Name ELVI BLOOD UREA NITROGEN
Applicant
VOLU SOL MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VOLU SOL MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDL  
Date Received11/26/1979
Decision Date 12/07/1979
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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