Clearance Summary
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE received FDA 510(k) clearance under submission number K050191, sponsored by Becton, Dickinson & CO. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2005-02-22.
- Submission: K050191
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2750
- Decision date: 2005-02-22
Classification & Regulation
This clearance is catalogued under FDA product code PER and 21 CFR 862.2750, within the Clinical Chemistry review panel as a Class I device.