K130253 is an FDA 510(k) clearance for the TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION. This device is classified as a Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (Class I - General Controls, product code PER).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 15, 2013, 164 days after receiving the submission on February 1, 2013.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.2750. 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) Number | K130253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2013 |
| Decision Date | July 15, 2013 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | PER — Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2750 |
| 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. |