BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel— 510(k) K214122
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K214122 for BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel, Substantially Equivalent on 2022-07-28. Applicant: Becton, Dickinson and Company. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code PCI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3990
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code PCI
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Data sourced from openFDA. This site is unofficial and independent of the FDA.