PER
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2750
- Medical specialty
- Clinical Chemistry
- FDA 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.
- Adverse events (MAUDE)
- 2020: 37 · 2021: 54 · 2022: 63
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BD FACS SAMPLE PREP ASSISTANT III (K131301) | Becton, Dickinson & CO | 2013-08-02 |
| TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION (K130253) | Beckman Coulter, Inc. | 2013-07-15 |
| MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE (K050191) | Becton, Dickinson & CO | 2005-02-22 |
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Every clearance here is in the API, with alerts when new ones post.