K210127 is an FDA 510(k) clearance for the iQ200 System, iChemVELOCITY Automated Urine Chemistry System. This device is classified as a Counter, Urine Particle (Class II - Special Controls, product code LKM).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 2, 2021, 164 days after receiving the submission on January 19, 2021.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K210127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2021 |
| Decision Date | July 02, 2021 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LKM — Counter, Urine Particle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |