ULTRACHEM T-BILI, #64971

Diazo Colorimetry, Bilirubin

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Ultrachem T-bili, #64971.

Pre-market Notification Details

Device IDK821462
510k NumberK821462
Device Name:ULTRACHEM T-BILI, #64971
ClassificationDiazo Colorimetry, Bilirubin
Applicant EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-18
Decision Date1982-06-01

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