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FDA 510(k)

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)

K-Number: K123903 · 2013-05-13

ApplicantBecton, Dickinson & CO
Decision Date2013-05-13
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2013-05-13 under 510(k) number K123903. 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 BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)?

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) is a medical device that received FDA 510(k) clearance on 2013-05-13. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K123903.

When did BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) receive FDA 510(k) clearance?

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) received FDA 510(k) clearance on 2013-05-13, under 510(k) number K123903.

Who is the listed applicant for BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)?

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

What is the FDA product code for BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)?

The FDA product code for BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) 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.

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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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