COBAS STANDARD FOR TOTAL PROTEIN

Fluorescent Immunoassay, Theophylline

HOFFMANN-LA ROCHE, INC.

The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Cobas Standard For Total Protein.

Pre-market Notification Details

Device IDK823576
510k NumberK823576
Device Name:COBAS STANDARD FOR TOTAL PROTEIN
ClassificationFluorescent Immunoassay, Theophylline
Applicant HOFFMANN-LA ROCHE, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLER  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-06
Decision Date1983-01-07

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