The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Tq-prep Workstation, Prepplus 2 Workstation.
| Device ID | K130253 |
| 510k Number | K130253 |
| Device Name: | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION |
| Classification | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147 AVE Miami, FL 33196 -2500 |
| Contact | Nancy Nadler |
| Correspondent | Nancy Nadler BECKMAN COULTER, INC. 11800 SW 147 AVE Miami, FL 33196 -2500 |
| Product Code | PER |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-01 |
| Decision Date | 2013-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590638191 | K130253 | 000 |
| 15099590563547 | K130253 | 000 |