FDA 510(k)

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY

K-Number: K063486 · 2007-03-07

Decision Date2007-03-07

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY 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 2007-03-07 under 510(k) number K063486. 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 MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY?

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY is a medical device that received FDA 510(k) clearance on 2007-03-07. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K063486.

When did BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY receive FDA 510(k) clearance?

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY received FDA 510(k) clearance on 2007-03-07, under 510(k) number K063486.

Who is the listed applicant for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY?

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 PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY?

The FDA product code for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY 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.