COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

Radioimmunoassay, Amikacin

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Fp Reagen For Amikacin & Amikacin Calibrator.

Pre-market Notification Details

Device IDK852317
510k NumberK852317
Device Name:COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
ClassificationRadioimmunoassay, Amikacin
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley,  NJ  07110
ContactDonald Kafader
CorrespondentDonald Kafader
ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley,  NJ  07110
Product CodeKLQ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-31
Decision Date1985-06-25

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