K241869 is an FDA 510(k) clearance for the BioSieve™ Fentanyl FIA Home Test Kit. This device is classified as a Test, Opiates, Over The Counter (Class II - Special Controls, product code NGL).
Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 4, 2024, 99 days after receiving the submission on June 27, 2024.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K241869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2024 |
| Decision Date | October 04, 2024 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NGL - Test, Opiates, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |