The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Tetracxp System (software And System Guide).
| Device ID | K030828 |
| 510k Number | K030828 |
| Device Name: | TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) |
| Classification | Counter, Differential Cell |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Stan Sugrue |
| Correspondent | Stan Sugrue BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590572839 | K030828 | 000 |
| 15099590547240 | K030828 | 000 |
| 15099590232948 | K030828 | 000 |
| 15099590232931 | K030828 | 000 |