BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
FDA 510(k) K192301 · Shenzhen Bioeasy Biotechnology Co., Ltd.
510(k) numberK192301
Submission
- Device name
- BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
- Applicant
- Shenzhen Bioeasy Biotechnology Co., Ltd.
Shenzhen, CN - Received
- August 23, 2019
- Decision date
- September 20, 2019
- 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 |
| K231978 | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx…NFW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/31/2023SE |
| 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 |
|---|---|---|
| K230238 | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup RxDJG · Traditional | 03/31/2023SE |
| K193480 | BIOEASY Multi-Drug Test CupNGL · Traditional | 01/31/2020SE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | 10/11/2019SE |
| K182530 | BIOEASY Multi-Drug Test CupNFT · Traditional | 11/09/2018SE |
Questions and answers
When was BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip cleared by the FDA?
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip (K192301) received a 510(k) decision of Substantially Equivalent on September 20, 2019, 28 days after the submission was received.
What is the product code of K192301?
The FDA product code is NFW – Test, Cannabinoid, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3870.