GLUCOSE/UREA NITROGEN STANDARD

Calibrator, Multi-analyte Mixture

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Glucose/urea Nitrogen Standard.

Pre-market Notification Details

Device IDK822937
510k NumberK822937
Device Name:GLUCOSE/UREA NITROGEN STANDARD
ClassificationCalibrator, Multi-analyte Mixture
Applicant EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-04
Decision Date1982-11-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.