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FDA 510(k)

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML

K-Number: K030091 · 2003-02-28

ApplicantBd Diagnostic Systems
Decision Date2003-02-28
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML is the device name listed in this FDA 510(k) record. The listed applicant is Bd Diagnostic Systems. It received FDA 510(k) clearance on 2003-02-28 under 510(k) number K030091. 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 - NORFLOXACIN 0.25 - 16 UG/ML?

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML is a medical device that received FDA 510(k) clearance on 2003-02-28. The listed applicant is Bd Diagnostic Systems. The 510(k) number is K030091.

When did BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML receive FDA 510(k) clearance?

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML received FDA 510(k) clearance on 2003-02-28, under 510(k) number K030091.

Who is the listed applicant for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML?

The FDA 510(k) record lists Bd Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML?

The FDA product code for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML is LON.

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Other records listing Bd Diagnostic Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260213BD BACTEC FXI Culture SystemK032518PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)K032153BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/MLK032259PASCO MIC AND MIC/ID PANELSK031429BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML

Related Devices (Code: LON)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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