Amedica Drug Screen Test Cup
FDA 510(k) K082898 · Amedica Biotech, Inc.
510(k) numberK082898
Submission
- Device name
- Amedica Drug Screen Test Cup
- Applicant
- Amedica Biotech, Inc.
Hayward, CA, US - Received
- September 30, 2008
- Decision date
- December 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NGL – Test, Opiates, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code NGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | Healgen Scientific,, LLC | 12/23/2025SE |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupNGL · Traditional | Anhui Deepblue Medical Technological Co., Ltd. | 04/15/2025SE |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProNGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/20/2025SE |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…NGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/06/2025SE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | Healgen Scientific,, LLC | 12/17/2024SE |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…NGL · Traditional | Eterbio, Inc. | 11/20/2024SE |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteNGL · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 11/08/2024SE |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve…NGL · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 10/04/2024SE |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…NGL · Traditional | Qingdao Hightop Biotech Co., Ltd. | 08/14/2024SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 07/16/2024SE |
More from Guangzhou Wondfo Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K100108 | Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, TcaNGL · Special | 04/14/2010SE |
| K080872 | Amedicheck Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma,Bar, BZLDJ · Special | 08/19/2008SE |
| K063379 | Amedica Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma, Bar, Bzo, M, Models C1210, C1220DKZ · Special | 12/11/2006SE |
| K061556 | Amedica Drug Screen THC, Coc,Opi,Amp,Met,Pcp,Mdma,Bar,Bzo,; Model C1010,C1015,C1020LDJ · Special | 07/21/2006SE |
| K040464 | Amedica Drug Screen Thc/Coc, OP1300, PPX, Oxy, Bar/Bzo TestLDJ · Traditional | 05/17/2004SE |
| K031497 | Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca TestDJC · Traditional | 10/17/2003SE |
| K023109 | Amedica Drug Screen Phencyclidine TestLCM · Traditional | 12/16/2002SE |
| K023104 | Amedica Drug Screen Amphetamine TestDKZ · Traditional | 12/16/2002SE |
| K023101 | Amedica Drug Screen Methaphetamine TestLAF · Traditional | 12/16/2002SE |
| K023047 | Amedica Drug Screen Opiates TestDJG · Traditional | 11/06/2002SE |
Questions and answers
When was Amedica Drug Screen Test Cup cleared by the FDA?
Amedica Drug Screen Test Cup (K082898) received a 510(k) decision of Substantially Equivalent on December 19, 2008, 80 days after the submission was received.
What is the product code of K082898?
The FDA product code is NGL – Test, Opiates, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3650.