K243996 is an FDA 510(k) clearance for the AssureTech Panel Dip Tests. This device is classified as a Test, Amphetamine, Over The Counter (Class II - Special Controls, product code NFT).
Submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on February 7, 2025, 43 days after receiving the submission on December 26, 2024.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K243996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2024 |
| Decision Date | February 07, 2025 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NFT - Test, Amphetamine, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |