Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, Tca
FDA 510(k) K100108 · Amedica Biotech, Inc.
510(k) numberK100108
Submission
- Device name
- Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, Tca
- Applicant
- Amedica Biotech, Inc.
Hayward, CA, US - Received
- January 14, 2010
- Decision date
- April 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| 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 |
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More from Guangzhou Wondfo Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K082898 | Amedica Drug Screen Test CupNGL · Traditional | 12/19/2008SE |
| 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 Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, Tca cleared by the FDA?
Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, Tca (K100108) received a 510(k) decision of Substantially Equivalent on April 14, 2010, 90 days after the submission was received.
What is the product code of K100108?
The FDA product code is NGL – Test, Opiates, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3650.