510(k) K130253 ยท PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 15, 2013 |
| Received | Feb 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.