BACT/ALERT FA 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 Fa Plus Culture Bottle.

Pre-market Notification Details

Device IDK121461
510k NumberK121461
Device Name:BACT/ALERT FA PLUS CULTURE BOTTLE
ClassificationSystem, Blood Culturing
Applicant BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
ContactJocelyn Jennings
CorrespondentJocelyn Jennings
BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-17
Decision Date2013-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026357900 K121461 000

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