ROCHE COBAS MIRA PLUS

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Mira Plus.

Pre-market Notification Details

Device IDK920402
510k NumberK920402
Device Name:ROCHE COBAS MIRA PLUS
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair,  NJ  07042
ContactCarol L Krieger
CorrespondentCarol L Krieger
ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair,  NJ  07042
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-31
Decision Date1992-04-29

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