Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
The Automated Pipetting, Diluting and Specimen Processing Workstation for Flow Cytometric Analysis is a clinical chemistry device consisting of automated or semi-automated workstations designed to prepare and process biological specimens prior to analysis by flow cytometry. It falls under the Clinical Chemistry medical specialty and is classified as a Class 1 device under regulation 862.2750, subject to general controls only. These workstations improve throughput and reproducibility in clinical flow cytometry laboratories. They are not implants and are not life-sustaining.
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Basic Information
- Product Code
- PER
- Device Class
- FDA class 1
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131301 | BD FACS SAMPLE PREP ASSISTANT III | Aug 02, 2013 | Substantially Equivalent | Becton, Dickinson & CO |
| K130253 | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | Jul 15, 2013 | Substantially Equivalent | Beckman Coulter, Inc. |
| K050191 | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE | Feb 22, 2005 | Substantially Equivalent | Becton, Dickinson & CO |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.