Submission Details
| 510(k) Number | K233062 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2023 |
| Decision Date | November 02, 2023 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
Nov 2023
Decision
37d
Days
Class 2
Risk
About This 510(k) Submission
K233062 is an FDA 510(k) clearance for the BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 2, 2023, 37 days after receiving the submission on September 26, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.
Device Classification
| Product Code | NFT — Test, Amphetamine, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3100 |
Manufacturer
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