MINIVIDAS INSTRUMENT

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

BIOMERIEUX VITEK, INC.

The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Minividas Instrument.

Pre-market Notification Details

Device IDK923579
510k NumberK923579
Device Name:MINIVIDAS INSTRUMENT
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2395
ContactChryl Winters-heard
CorrespondentChryl Winters-heard
BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2395
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-20
Decision Date1993-02-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026140441 K923579 000

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