BD MAX Extended Enteric Bacterial Panel, BD MAX System— 510(k) K170308
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K170308 for BD MAX Extended Enteric Bacterial Panel, BD MAX System, Substantially Equivalent on 2017-05-02. Applicant: Becton, Dickinson and Company. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code PCH
- 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
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Recalls naming K170308
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170308.
Data sourced from openFDA. This site is unofficial and independent of the FDA.