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FDA 510(k)

BD BACTEC Peds Plus/F Culture Vials (plastic)

K-Number: K151866 · 2016-02-25

ApplicantBecton, Dickinson and Company
Decision Date2016-02-25
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD BACTEC Peds Plus/F Culture Vials (plastic) 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 2016-02-25 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K151866.

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

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

Who is the listed applicant for BD BACTEC Peds Plus/F Culture Vials (plastic)?

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 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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Other records listing Becton, Dickinson and Company as applicant

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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 SystemsK222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and CompanyK222559BD 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 Company

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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