FDA.reportPublic FDA data

510(k) K222591

Device
BD BACTEC? Plus Aerobic/F Culture Vials
Applicant
Becton, Dickinson and Company
510(k) number
K222591
Product code
MDB
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-24
Date received
2022-08-26
Regulation
866.2560
Classification name
System, Blood Culturing
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Susan Kircher
Address
7loveton Cir. Sparks MD US 21152 21152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MDB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company2023-03-24
K190405BACT/ALERT MP Reagent SystembioMerieux, Inc.2019-05-15
K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.2019-02-11
K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and Company2018-03-16
K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, Inc.2017-03-28
K161810BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson2017-02-09
K161306BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson2016-08-08
K151866BD BACTEC Peds Plus/F Culture Vials (plastic)Becton, Dickinson and Company2016-02-25
K141810BD BACTEC PLUS ANAEROBIC/F (PLASTIC)Becton, Dickinson and Company2014-12-10
K123903BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)Becton, Dickinson & CO2013-05-13
K121446BACT/ALERT PF PLUS CULTURE BOTTLEbioMerieux, Inc.2013-01-25
K121455BACT/ALERT FN PLUS CULTURE BOTTLEbioMerieux, Inc.2013-01-25
K121461BACT/ALERT FA PLUS CULTURE BOTTLEbioMerieux, Inc.2013-01-22
K120994BD BACTEC Plus PRIME Aerobic/F Culture VialsBecton, Dickinson and Company2012-08-07
K113558BD BACTEC Plus Aerobic/F Culture Vials (plastic)Becton, Dickinson and Company2012-03-16