ASTRA TOTAL PROTEIN REAGENT

Biuret (colorimetric), Total Protein

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Astra Total Protein Reagent.

Pre-market Notification Details

Device IDK813536
510k NumberK813536
Device Name:ASTRA TOTAL PROTEIN REAGENT
ClassificationBiuret (colorimetric), Total Protein
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-18
Decision Date1981-12-31

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