Ameditech, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Ameditech, Inc.” (first 2001, latest 2011), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 5 | 5 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Ameditech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) | DIO | 2011-12-05 | 10 |
| K113046 | AMEDITECH IMMUTEST MILTI-DRUG SCREEN | DKZ | 2011-11-10 | 28 |
| K063015 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 | DJG | 2006-12-20 | 79 |
| K053175 | AMEDITECH DRUGSMARTCUP | DKZ | 2005-12-08 | 24 |
| K050186 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III | DKZ | 2005-03-04 | 36 |
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | DIS | 2004-12-29 | 62 |
| K040092 | AMEDITECH IMMU TEST DRUG SCREEN PANEL | DKZ | 2004-03-08 | 52 |
| K023126 | AMEDITECH IMMUTEST HCG PREGANCY TEST | LCX | 2002-11-18 | 60 |
| K012582 | AMEDITECH IMMUTEST DRUG SCREEN PCP | LCM | 2001-11-30 | 112 |
| K012484 | AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE | DKZ | 2001-11-30 | 120 |
4 earlier clearances. See the full list in Caduvo.
Recalls
111 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2020-08-18.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ameditech, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Ameditech, Inc.” (first 2001, latest 2011), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ameditech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ameditech, Inc. is 70 days.
Which FDA product codes appear under Ameditech, Inc.?
The most frequent FDA product codes under this applicant name are DKZ (Enzyme Immunoassay, Amphetamine, 5); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 2); DJG (Enzyme Immunoassay, Opiates, 2).
Next steps
- See all 14 Ameditech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Ameditech, 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.