K210452 is an FDA 510(k) clearance for the Creatinine2. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II - Special Controls, product code CGX).
Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on March 22, 2022, 399 days after receiving the submission on February 16, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K210452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2021 |
| Decision Date | March 22, 2022 |
| Days to Decision | 399 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGX - Alkaline Picrate, Colorimetry, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |