The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Tetrachrome Reagents And Tetracxp System.
| Device ID | K121445 |
| 510k Number | K121445 |
| Device Name: | TETRACHROME REAGENTS AND TETRACXP SYSTEM |
| Classification | Flow Cytometric Reagents And Accessories. |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Contact | Nancy Nadler |
| Correspondent | Nancy Nadler BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Product Code | OYE |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-15 |
| Decision Date | 2013-07-26 |
| Summary: | summary |