BACT/ALERT FN PLUS CULTURE BOTTLE

System, Blood Culturing

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Fn Plus Culture Bottle.

Pre-market Notification Details

Device IDK121455
510k NumberK121455
Device Name:BACT/ALERT FN PLUS CULTURE BOTTLE
ClassificationSystem, Blood Culturing
Applicant BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
ContactPatricia Murphy
CorrespondentPatricia Murphy
BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-16
Decision Date2013-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026357917 K121455 000

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