Amedica Biotech, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Amedica Biotech, Inc.” (first 2002, latest 2010), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | 4 | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 2 |
| NGL | Test, Opiates, Over The Counter | 2 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
Review panels
- Clinical Toxicology (13)
Most recent Amedica Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100108 | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA | NGL | 2010-04-14 | 90 |
| K082898 | AMEDICA DRUG SCREEN TEST CUP | NGL | 2008-12-19 | 80 |
| K080872 | AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ | LDJ | 2008-08-19 | 141 |
| K063379 | AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 | DKZ | 2006-12-11 | 33 |
| K061556 | AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 | LDJ | 2006-07-21 | 46 |
| K040464 | AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST | LDJ | 2004-05-17 | 84 |
| K031497 | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST | DJC | 2003-10-17 | 157 |
| K023109 | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST | LCM | 2002-12-16 | 89 |
| K023104 | AMEDICA DRUG SCREEN AMPHETAMINE TEST | DKZ | 2002-12-16 | 89 |
| K023101 | AMEDICA DRUG SCREEN METHAPHETAMINE TEST | LAF | 2002-12-16 | 89 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amedica Biotech, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Amedica Corp. (17 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Amedica Biotech, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Amedica Biotech, Inc.” (first 2002, latest 2010), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Amedica Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amedica Biotech, Inc. is 84 days.
Which FDA product codes appear under Amedica Biotech, Inc.?
The most frequent FDA product codes under this applicant name are LDJ (Enzyme Immunoassay, Cannabinoids, 4); DKZ (Enzyme Immunoassay, Amphetamine, 2); NGL (Test, Opiates, Over The Counter, 2).
Next steps
- See all 13 Amedica Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LDJ, Amedica Biotech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.