Company ยท US
Amedica Biotech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2010. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 |
| NGL | Test, Opiates, Over The Counter | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2010 | K100108 | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA Amedica Biotech, Inc. | NGL |
| Dec 19, 2008 | K082898 | AMEDICA DRUG SCREEN TEST CUP Amedica Biotech, Inc. | NGL |
| Aug 19, 2008 | K080872 | AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ Amedica Biotech, Inc. | LDJ |
| Dec 11, 2006 | K063379 | AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 Amedica Biotech, Inc. | DKZ |
| Jul 21, 2006 | K061556 | AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 Amedica Biotech, Inc. | LDJ |
| May 17, 2004 | K040464 | AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST Amedica Biotech, Inc. | LDJ |
| Oct 17, 2003 | K031497 | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST Amedica Biotech, Inc. | DJC |
| Dec 16, 2002 | K023109 | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST Amedica Biotech, Inc. | LCM |
| Dec 16, 2002 | K023104 | AMEDICA DRUG SCREEN AMPHETAMINE TEST Amedica Biotech, Inc. | DKZ |
| Dec 16, 2002 | K023101 | AMEDICA DRUG SCREEN METHAPHETAMINE TEST Amedica Biotech, Inc. | LAF |
| Nov 6, 2002 | K023047 | AMEDICA DRUG SCREEN OPIATES TEST Amedica Biotech, Inc. | DJG |
| Nov 6, 2002 | K022955 | AMEDICA DRUG SCREEN THC TEST Amedica Biotech, Inc. | LDJ |
| Nov 6, 2002 | K022954 | AMEDICA DRUG SCREEN COCAINE TEST Amedica Biotech, Inc. | DIO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||