Amedica Drug Screen Phencyclidine Test
FDA 510(k) K023109 · Amedica Biotech, Inc.
510(k) numberK023109
Submission
- Device name
- Amedica Drug Screen Phencyclidine Test
- Applicant
- Amedica Biotech, Inc.
Hayward, CA, US - Received
- September 18, 2002
- Decision date
- December 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCM – Enzyme Immunoassay, Phencyclidine
- Device class
- Unclassified
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| K122703 | Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…LCM · Traditional | Biophor Diagnostics, Inc. | 04/25/2013SE |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayLCM · Traditional | Microgenics Corp. | 04/08/2011SE |
More from Microgenics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K100108 | Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, TcaNGL · Special | 04/14/2010SE |
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| 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 |
| 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 Phencyclidine Test cleared by the FDA?
Amedica Drug Screen Phencyclidine Test (K023109) received a 510(k) decision of Substantially Equivalent on December 16, 2002, 89 days after the submission was received.
What is the product code of K023109?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.