SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
FDA 510(k) K182654 · Safecare Biotech (Hangzhou) Co., Ltd.
510(k) numberK182654
Submission
- Device name
- SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
Hangzhou, CN - Received
- September 25, 2018
- Decision date
- November 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGG – Test, Methamphetamine, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
More from Safecare Biotech (Hangzhou) 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 |
| K191924 | SAFECARE® THC Urine Strip TestNFW · Traditional | 08/16/2019SE |
| 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 Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card cleared by the FDA?
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K182654) received a 510(k) decision of Substantially Equivalent on November 19, 2018, 55 days after the submission was received.
What is the product code of K182654?
The FDA product code is NGG – Test, Methamphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3610.