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FDA 510(k)

BD BACTEC™ Plus Aerobic/F Culture Vials

K-Number: K222591 · 2023-03-24

ApplicantBecton, Dickinson and Company
Decision Date2023-03-24
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD BACTEC™ Plus Aerobic/F Culture Vials is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K222591. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD BACTEC™ Plus Aerobic/F Culture Vials?

BD BACTEC™ Plus Aerobic/F Culture Vials is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K222591.

When did BD BACTEC™ Plus Aerobic/F Culture Vials receive FDA 510(k) clearance?

BD BACTEC™ Plus Aerobic/F Culture Vials received FDA 510(k) clearance on 2023-03-24, under 510(k) number K222591.

Who is the listed applicant for BD BACTEC™ Plus Aerobic/F Culture Vials?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD BACTEC™ Plus Aerobic/F Culture Vials?

The FDA product code for BD BACTEC™ Plus Aerobic/F Culture Vials is MDB.

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Related Devices (Code: MDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260213BD BACTEC FXI Culture SystemBD Diagnostic SystemsK222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and CompanyK190405BACT/ALERT MP Reagent SystembioMerieux, Inc.K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and CompanyK161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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