510(k) K131301
K131301 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD FACS SAMPLE PREP ASSISTANT III". The FDA issued a decision of Substantially Equivalent on August 2, 2013. 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
- August 2, 2013
- Date Received
- May 7, 2013
- Clearance Type
- Traditional
- 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.