The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for 4c-es Cell, Models 7547187, 7547188, 7547189, 7547190.
| Device ID | K010064 |
| 510k Number | K010064 |
| Device Name: | 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Contact | Stan Sugrue |
| Correspondent | Stan Sugrue BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-08 |
| Decision Date | 2001-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590230333 | K010064 | 000 |
| 15099590222314 | K010064 | 000 |
| 15099590222307 | K010064 | 000 |
| 15099590222291 | K010064 | 000 |
| 15099590222277 | K010064 | 000 |