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FDA 510(k)

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

K-Number: K163637 · 2017-03-21

ApplicantBecton Dickinson & Company
Decision Date2017-03-21
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson & Company. It received FDA 510(k) clearance on 2017-03-21 under 510(k) number K163637. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)?

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) is a medical device that received FDA 510(k) clearance on 2017-03-21. The listed applicant is Becton Dickinson & Company. The 510(k) number is K163637.

When did BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) receive FDA 510(k) clearance?

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) received FDA 510(k) clearance on 2017-03-21, under 510(k) number K163637.

Who is the listed applicant for BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)?

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

What is the FDA product code for BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)?

The FDA product code for BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) is LON.

Other records listing Becton Dickinson & Company as applicant

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Related Devices (Code: LON)

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.

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUXK251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and CompanyK250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and CompanyK234012VITEK COMPACT PRObioMerieux, 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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