FDA 510(k)

BD BACTEC Peds Plus/F Culture Vials (plastic)

K-Number: K151866 · 2016-02-25

Decision Date2016-02-25

Product CodeMDB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD BACTEC Peds Plus/F Culture Vials (plastic) is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-02-25 under approval number K151866. 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 Peds Plus/F Culture Vials (plastic)?

BD BACTEC Peds Plus/F Culture Vials (plastic) is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K151866.

When was BD BACTEC Peds Plus/F Culture Vials (plastic) approved by the FDA?

BD BACTEC Peds Plus/F Culture Vials (plastic) received FDA 510(k) clearance on 2016-02-25, under approval number K151866.

What company makes BD BACTEC Peds Plus/F Culture Vials (plastic)?

BD BACTEC Peds Plus/F Culture Vials (plastic) is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD BACTEC Peds Plus/F Culture Vials (plastic)?

The FDA product code for BD BACTEC Peds Plus/F Culture Vials (plastic) is MDB.

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Related Devices (Code: MDB)

K161306BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, Inc. K161810BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and Company K190405BACT/ALERT MP Reagent SystembioMerieux, Inc. K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.

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.