Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca Test
FDA 510(k) K031497 · Amedica Biotech, Inc.
510(k) numberK031497
Submission
- Device name
- Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca Test
- Applicant
- Amedica Biotech, Inc.
Hayward, CA, US - Received
- May 13, 2003
- Decision date
- October 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DJC – Thin Layer Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
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More from Varian, 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 |
| 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 |
| 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 Mdma-Bar-Bzo-Mtd-Tca Test cleared by the FDA?
Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca Test (K031497) received a 510(k) decision of Substantially Equivalent on October 17, 2003, 157 days after the submission was received.
What is the product code of K031497?
The FDA product code is DJC – Thin Layer Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.