K213875 is an FDA 510(k) clearance for the DRI TM Tricyclics Serum Tox Assay. This device is classified as a U.v. Spectrometry, Tricyclic Antidepressant Drugs (Class II - Special Controls, product code LFH).
Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on December 21, 2022, 373 days after receiving the submission on December 13, 2021.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3910.
| 510(k) Number | K213875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2021 |
| Decision Date | December 21, 2022 |
| Days to Decision | 373 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LFH — U.v. Spectrometry, Tricyclic Antidepressant Drugs |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3910 |