BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

System, Blood Culturing

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Mp Culture Bottles (plastic).

Pre-market Notification Details

Device IDK031737
510k NumberK031737
Device Name:BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
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 Received2003-06-04
Decision Date2003-07-14
Summary:summary

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