510(k) K050191
K050191 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE". The FDA issued a decision of Substantially Equivalent on February 22, 2005. The device falls under product code PER (Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis), a Class I device regulated under 21 CFR 862.2750. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2005
- Date Received
- January 27, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- Device Class
- Class I
- Regulation Number
- 862.2750
- Review Panel
- CH
- Submission Type
Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.