FDA 510(k)

BD BACTEC Myco/F Lytic Culture Vials

K-Number: K222559 · 2023-03-24

Decision Date2023-03-24

Product CodeMDB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD BACTEC Myco/F Lytic Culture Vials is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-03-24 under approval number K222559. 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 Myco/F Lytic Culture Vials?

BD BACTEC Myco/F Lytic Culture Vials is a medical device that received FDA 510(k) clearance on 2023-03-24. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K222559.

When was BD BACTEC Myco/F Lytic Culture Vials approved by the FDA?

BD BACTEC Myco/F Lytic Culture Vials received FDA 510(k) clearance on 2023-03-24, under approval number K222559.

What company makes BD BACTEC Myco/F Lytic Culture Vials?

BD BACTEC Myco/F Lytic Culture Vials is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD BACTEC Myco/F Lytic Culture Vials?

The FDA product code for BD BACTEC Myco/F Lytic Culture Vials is MDB.

Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024)

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Official Source

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