510(k) K231978
- Device
- 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.
- 510(k) number
- K231978
- Product code
- NFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-31
- Date received
- 2023-07-03
- Regulation
- 862.3870
- Classification name
- Test, Cannabinoid, Over The Counter
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jessica Chen
- Address
- Floor 2, Block 2, 146 E. Chaofeng Rd. Yuhang Economy Development Zone Hangzhou CN 311100 311100
FDA Registration Numbers#
- 3043127647
- 3015821396
- 3010934853
- 3014223276
- 3007606081
- 3008741972
- 3009238284
- 3031697086
- 3023296261
- 3027519599
- 3012725363
- 3016447251
- 3030413233
- 1649661
- 2060833
- 3025349997
- 3013223546
- 3030648160
- 3023322455
- 3010852191
- 3005345870
- 2029372
- 3009585529
- 3032147516
- 3036649420
- 3013077867
- 3021186226
- 3008517993
- 3012073813
- 3005360469
- 2087033
- 3010220539
- 3009414546
- 3024463179
- 3004635103
- 3005984081
- 3024753119
- 3038614708
- 1910144
- 3006048451
- 3025041446
- 3003917514
- 3009212837
- 3017904598
- 2030633
- 3042271096
- 3011522054
- 3014301129
Source Documents#
Other 510(k) Records For Product Code NFW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026-02-12 |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-09-20 |
| K191924 | SAFECARE® THC Urine Strip Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2019-08-16 |