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FDA 510(k)

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML

K-Number: K032153 · 2003-09-11

ApplicantBd Diagnostic Systems
Decision Date2003-09-11
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 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 2003-09-11 under 510(k) number K032153. 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 CEFOTAXIME 0.5-64 UG/ML?

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML is a medical device that received FDA 510(k) clearance on 2003-09-11. The listed applicant is Bd Diagnostic Systems. The 510(k) number is K032153.

When did BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML receive FDA 510(k) clearance?

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML received FDA 510(k) clearance on 2003-09-11, under 510(k) number K032153.

Who is the listed applicant for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 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 CEFOTAXIME 0.5-64 UG/ML?

The FDA product code for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 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)K032259PASCO MIC AND MIC/ID PANELSK031429BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/MLK030091BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 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.

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUXK251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and CompanyK250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and CompanyK234012VITEK COMPACT PRObioMerieux, Inc.

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.

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