| 2025-12-23 |
K253567 |
Healgen Scientific,, LLC
|
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
| 2025-04-15 |
K250803 |
Anhui Deepblue Medical Technological Co., Ltd.
|
Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup |
| 2025-02-20 |
K250067 |
Guangzhou Decheng Biotechnology Co., Ltd.
|
Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro |
| 2025-02-06 |
K242428 |
Guangzhou Decheng Biotechnology Co., Ltd.
|
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus |
| 2024-12-17 |
K243365 |
Healgen Scientific,, LLC
|
Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup |
| 2024-11-20 |
K243064 |
Eterbio, Inc.
|
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test |
| 2024-11-08 |
K242802 |
Hangzhou Clongene Biotech Co., Ltd.
|
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette |
| 2024-10-04 |
K241869 |
Vivachek Biotech (Hangzhou) Co., Ltd.
|
BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader |
| 2024-08-14 |
K241969 |
Qingdao Hightop Biotech Co., Ltd.
|
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel |
| 2024-07-16 |
K241741 |
Guangzhou Wondfo Biotech Co., Ltd.
|
SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel |
| 2024-05-22 |
K241100 |
Co-Innovation Biotech Co., Ltd.
|
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard |
| 2024-05-13 |
K240949 |
Healgen Scientific,, LLC
|
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) |
| 2024-04-12 |
K240686 |
Healgen Scientific,, LLC
|
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
| 2024-04-10 |
K240654 |
Safecare Biotech (Hangzhou) Co., Ltd.
|
SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette |
| 2024-03-28 |
K240295 |
Instanosis, Inc.
|
InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) |
| 2024-03-21 |
K234006 |
Allsource Screening Solutions
|
AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test |
| 2024-03-06 |
K240351 |
Assure Tech., LLC
|
FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) |
| 2023-10-26 |
K233417 |
Hangzhou AllTest Biotech Co., Ltd.
|
AllTest Fentanyl Urine Test Cassette |
| 2020-01-31 |
K193480 |
Shenzhen Bioeasy Biotechnology Co., Ltd.
|
BIOEASY Multi-Drug Test Cup |