PER · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Clinical Chemistry · 21 CFR 862.2750 · Class 1
Overview
| Product Code | PER |
|---|---|
| Device Name | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Regulation | 21 CFR 862.2750 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131301 | BD FACS SAMPLE PREP ASSISTANT III | Becton, Dickinson & CO | Aug 2, 2013 | SESE |
| K130253 | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | Beckman Coulter, Inc. | Jul 15, 2013 | SESE |
| K050191 | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE | Becton, Dickinson & CO | Feb 22, 2005 | SESE |
Top Applicants
- Becton, Dickinson & CO — 2 clearances
- Beckman Coulter, Inc. — 1 clearance
