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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 K831414
Device Name COLORIMETRIC BUN
Applicant
BIO-ANALYTICS LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIO-ANALYTICS LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDL  
Date Received05/02/1983
Decision Date 06/16/1983
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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