Submission Details
| 510(k) Number | K240124 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2024 |
| Decision Date | June 14, 2024 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
BioSieve? Fentanyl FIA Test Kit; BioSieve? ToxiSmart FIA Reader
Jun 2024
Decision
150d
Days
Class 2
Risk
About This 510(k) Submission
K240124 is an FDA 510(k) clearance for the BioSieve? Fentanyl FIA Test Kit; BioSieve? ToxiSmart FIA Reader, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 14, 2024, 150 days after receiving the submission on January 16, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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