Submission Details
| 510(k) Number | K243462 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Diazyme Colorimetric Lithium Assay
Aug 2025
Decision
266d
Days
Class 2
Risk
About This 510(k) Submission
K243462 is an FDA 510(k) clearance for the Diazyme Colorimetric Lithium Assay, 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 review panel. Regulated under 21 CFR 862.3560.
Device Classification
| Product Code | NDW — Assay, Porphyrin, Spectrophotometry, Lithium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3560 |
Manufacturer
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