K243462 is an FDA 510(k) clearance for the Diazyme Colorimetric Lithium Assay. This device is classified as a Assay, Porphyrin, Spectrophotometry, Lithium (Class II - Special Controls, product code NDW).
Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on August 1, 2025, 266 days after receiving the submission on November 8, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3560.
| 510(k) Number | K243462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | August 01, 2025 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | NDW — Assay, Porphyrin, Spectrophotometry, Lithium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3560 |