PER — Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis Class I
FDA product code PER covers "Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis", a Class I medical device regulated under 21 CFR 862.2750. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PER
- Device Class
- Class I
- Regulation Number
- 862.2750
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131301 | becton, dickinson and | BD FACS SAMPLE PREP ASSISTANT III | August 2, 2013 |
| K130253 | beckman coulter | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | July 15, 2013 |
| K050191 | becton, dickinson and | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE | February 22, 2005 |