Atlas FDA

BD BACTEC™ Myco/F Lytic Culture Vials

FDA 510(k) clearance K222559 · decided 2023-03-24

Clearance details

K-number
K222559
Device name
BD BACTEC™ Myco/F Lytic Culture Vials
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2022-08-24
Decision date
2023-03-24
Days to decision
212 days
Clearance type
Traditional
Product code
MDB
Device class
1
Regulation number
866.2560
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Sparks, MD, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BD BACTEC FXI Culture System (K260213)BD Diagnostic Systems2026-05-28
BD BACTEC™ Plus Aerobic/F Culture Vials (K222591)Becton, Dickinson and Company2023-03-24
BACT/ALERT MP Reagent System (K190405)bioMerieux, Inc.2019-05-15
BacT/ALERT FA Plus; BacT/ALERT PF Plus (K183166)bioMerieux, Inc.2019-02-11
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial (K173873)Becton, Dickinson and Company2018-03-16
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816)bioMerieux, Inc.2017-03-28
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810)Becton Dickinson2017-02-09
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306)Becton Dickinson2016-08-08
BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866)Becton, Dickinson and Company2016-02-25
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810)Becton, Dickinson and Company2014-12-10
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903)Becton, Dickinson & CO2013-05-13
BACT/ALERT FN PLUS CULTURE BOTTLE (K121455)bioMerieux, Inc.2013-01-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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BD Onclarity HPV Assay (P160037/S018)Becton, Dickinson and Company2023-11-20
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