BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50
FDA 510(k) K231978 · Vivachek Biotech (Hangzhou) Co., Ltd.
510(k) numberK231978
Submission
- Device name
- BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
Hangzhou, CN - Received
- July 3, 2023
- Decision date
- August 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NFW – Test, Cannabinoid, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
Other 510(k)s with product code NFW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestNFW · Traditional | Healgen Scientific,, LLC | 02/12/2026SE |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripNFW · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 09/20/2019SE |
| K191924 | SAFECARE® THC Urine Strip TestNFW · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 08/16/2019SE |
More from Safecare Biotech (Hangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelNFT · Traditional | 05/22/2026SE |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT · Traditional | 09/12/2025SE |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve…NGL · Traditional | 10/04/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | 08/16/2024SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | 06/14/2024SE |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring SystemNBW · Traditional | 12/22/2023SE |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxNFT · Traditional | 11/02/2023SE |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxNFT · Traditional | 11/10/2022SE |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN · Traditional | 06/05/2020SE |
Questions and answers
When was BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50 cleared by the FDA?
BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50 (K231978) received a 510(k) decision of Substantially Equivalent on August 31, 2023, 59 days after the submission was received.
What is the product code of K231978?
The FDA product code is NFW – Test, Cannabinoid, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3870.