FDA 510(k)

BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN

K-Number: K123266 · 2013-06-26

Decision Date2013-06-26

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN 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 2013-06-26 under 510(k) number K123266. 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 MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN?

BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN is a medical device that received FDA 510(k) clearance on 2013-06-26. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K123266.

When did BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN receive FDA 510(k) clearance?

BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN received FDA 510(k) clearance on 2013-06-26, under 510(k) number K123266.

Who is the listed applicant for BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN?

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 MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN?

The FDA product code for BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN is 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.