DATA-ZYME UREA NITROGEN, COLORIMETRIC

Berthelot Indophenol, Urea Nitrogen

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Data-zyme Urea Nitrogen, Colorimetric.

Pre-market Notification Details

Device IDK801727
510k NumberK801727
Device Name:DATA-ZYME UREA NITROGEN, COLORIMETRIC
ClassificationBerthelot Indophenol, Urea Nitrogen
Applicant DATA MEDICAL ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDL  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-07-24
Decision Date1980-09-09

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