FDA 510(k)

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)

Número K: K233986 · 2024-03-15

Data da decisão2024-03-15

Código do produtoLON

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) 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 2024-03-15 under 510(k) number K233986. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)?

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K233986.

When did BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) receive FDA 510(k) clearance?

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K233986.

Who is the listed applicant for BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)?

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 Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)?

The FDA product code for BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) is LON.

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Fonte oficial

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