VITEK 2 GRAM NEGATIVE DOXYCYCLINE

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Gram Negative Doxycycline.

Pre-market Notification Details

Device IDK121546
510k NumberK121546
Device Name:VITEK 2 GRAM NEGATIVE DOXYCYCLINE
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactJennifer Chia-hsuan Lin
CorrespondentJennifer Chia-hsuan Lin
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-25
Decision Date2012-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026635466 K121546 000
03573026635442 K121546 000

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