Amedica Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma, Bar, Bzo, M, Models C1210, C1220
FDA 510(k) K063379 · Amedica Biotech, Inc.
510(k) numberK063379
Submission
- Device name
- Amedica Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma, Bar, Bzo, M, Models C1210, C1220
- Applicant
- Amedica Biotech, Inc.
Hayward, CA, US - Received
- November 8, 2006
- Decision date
- December 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100108 | Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, TcaNGL · Special | 04/14/2010SE |
| 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 |
| 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 THC, Coc, Opi, Amp, Met, PCP, Mdma, Bar, Bzo, M, Models C1210, C1220 cleared by the FDA?
Amedica Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma, Bar, Bzo, M, Models C1210, C1220 (K063379) received a 510(k) decision of Substantially Equivalent on December 11, 2006, 33 days after the submission was received.
What is the product code of K063379?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.