MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE— 510(k) K050191
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K050191 for MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE, Substantially Equivalent on 2005-02-22. Applicant: Becton, Dickinson & CO. Device class: 1.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code PER
- Device class
- Class 1
- Regulation
- 21 CFR 862.2750
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
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Recalls naming K050191
K-number listed on FDA's recall record- Z-2356-2020 — BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
- Z-2357-2020 — BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050191.
Data sourced from openFDA. This site is unofficial and independent of the FDA.