SAFECARE® THC Urine Strip Test
FDA 510(k) K191924 · Safecare Biotech (Hangzhou) Co., Ltd.
510(k) numberK191924
Submission
- Device name
- SAFECARE® THC Urine Strip Test
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
Hangzhou, CN - Received
- July 18, 2019
- Decision date
- August 16, 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 |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripNFW · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 09/20/2019SE |
More from Shenzhen Bioeasy Biotechnology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242767 | Safecare Urinary Tract Infection TestJMT · Traditional | 01/10/2025SE |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteNGL · Traditional | 04/10/2024SE |
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT · Traditional | 03/24/2021SE |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamLCX · Traditional | 08/13/2020SE |
| K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardNFT · Traditional | 05/27/2020SE |
| K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardNGG · Traditional | 11/19/2018SE |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT · Traditional | 08/20/2018SE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional | 03/18/2016SE |
Questions and answers
When was SAFECARE® THC Urine Strip Test cleared by the FDA?
SAFECARE® THC Urine Strip Test (K191924) received a 510(k) decision of Substantially Equivalent on August 16, 2019, 29 days after the submission was received.
What is the product code of K191924?
The FDA product code is NFW – Test, Cannabinoid, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3870.