K203833 is an FDA 510(k) clearance for the Tacrolimus Assay Kit. This device is classified as a Enzyme Immunoassay, Tracrolimus (Class II - Special Controls, product code MLM).
Submitted by Shanghai Genext Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 27, 2023, 758 days after receiving the submission on December 30, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1678.
| 510(k) Number | K203833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2020 |
| Decision Date | January 27, 2023 |
| Days to Decision | 758 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MLM - Enzyme Immunoassay, Tracrolimus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1678 |