The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Iq200 System, Ichemvelocity Automated Urine Chemistry System.
| Device ID | K210127 |
| 510k Number | K210127 |
| Device Name: | IQ200 System, IChemVELOCITY Automated Urine Chemistry System |
| Classification | Counter, Urine Particle |
| Applicant | Beckman Coulter, Inc. 11800 SW 147th Ave Miami, FL 33196 |
| Contact | Marisa Pugliese |
| Correspondent | Marisa Pugliese Beckman Coulter, Inc. 11800 SW 147th Ave Miami, FL 33196 |
| Product Code | LKM |
| Subsequent Product Code | GKL |
| Subsequent Product Code | JIL |
| Subsequent Product Code | KQO |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-07-02 |