Panels › Clinical Chemistry › Product code PER · Class 1
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Regulation 862.2750
0510(k)s in 12 months (3 all time)
1recalls in 12 months (10 all time)
5recalls that name a 510(k)
Top companies in PER
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | Beckman Coulter, Inc. CellMek SPS Sample Preparation System, REF: C44603, with software Open, Classified |
PER | None listed |
| Oct 30, 2025 | Beckman Coulter, Inc. CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. Open, Classified |
PER | None listed |
| Feb 5, 2025 | Sysmex America, Inc. Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.
Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytom Open, Classified |
PER | None listed |
| Oct 3, 2024 | Becton, Dickinson and Company, BD Bio Sciences BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1.
Intended use: to prepare human s Open, Classified |
PER | None listed |
| Jul 6, 2020 | Sysmex America, Inc. Sysmex PS-10 Sample Preparation System
Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis Terminated |
PER | None listed |
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry s Terminated |
PER | K131301 |
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intende Terminated |
PER | K050191 |
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for us Terminated |
PER | K050191 |
| May 22, 2017 | Beckman Coulter Inc. Coulter PrepPlus 2, Part Number 378600,
Product Usage:
The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Terminated |
PER | K130253 |
| May 22, 2017 | Beckman Coulter Inc. Coulter PrepPlus, Part Number 286600,
Product Usage:
The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. Terminated |
PER | K130253 |
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