FDA 510(k)

BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML

K-Number: K050780 · 2005-05-12

Decision Date2005-05-12

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML 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 2005-05-12 under 510(k) number K050780. 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 PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML?

BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML is a medical device that received FDA 510(k) clearance on 2005-05-12. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K050780.

When did BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML receive FDA 510(k) clearance?

BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML received FDA 510(k) clearance on 2005-05-12, under 510(k) number K050780.

Who is the listed applicant for BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML?

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 BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML?

The FDA product code for BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML is LON.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.