BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM— 510(k) K020323
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K020323 for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, Substantially Equivalent on 2002-04-04. Applicant: Becton, Dickinson & CO. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code LON
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- K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
- K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
- K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
More clearances from Becton, Dickinson & CO
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- K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
Adverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.