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FDA 510(k)

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)

K-Number: K173252 · 2018-01-05

ApplicantBecton, Dickinson and Company
Decision Date2018-01-05
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2018-01-05 under approval number K173252. 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 Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)?

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2018-01-05. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K173252.

When was BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) approved by the FDA?

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) received FDA 510(k) clearance on 2018-01-05, under approval number K173252.

What company makes BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)?

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) is manufactured by Becton, Dickinson and Company.

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

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

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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Related Devices (Code: LON)

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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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