Ameritek, Inc.: FDA clearances and approvals
Ameritek, Inc. has 17 FDA 510(k) clearances (first 1986, latest 2000), across 15 product codes in 4 review panels. Median 510(k) review time: 68 days.
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 | 2 | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| HNH | Ring, Ophthalmic (Flieringa) | 1 | 1 |
| HPN | Magnet, Permanent | 1 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (6)
- Clinical Toxicology (6)
- Ophthalmic (4)
- Hematology (1)
Most recent Ameritek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001215 | DBEST HCG 2 IU/ML TEST KIT | JHI | 2000-06-22 | 69 |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | JMT | 1999-09-01 | 169 |
| K990681 | DBSET MULTIDRUG SCREEN TEST KIT | DKZ | 1999-07-15 | 135 |
| K984269 | DBEST OCCULT BLOOD TEST KIT | KHE | 1999-05-11 | 201 |
| K983191 | DBEST COCAINE TEST KIT | DIO | 1998-11-18 | 68 |
| K983190 | DBEST OPIATES TEST KIT | DJG | 1998-11-18 | 68 |
| K983189 | DBEST METHAMPHETAMINES TEST KIT | LAF | 1998-11-18 | 68 |
| K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT | LDJ | 1998-11-18 | 68 |
| K981504 | DBEST AMPHETAMINES TEST KIT | DKZ | 1998-08-06 | 101 |
| K974508 | DBEST ONE-STEP OVULATION TEST | CEP | 1998-02-02 | 63 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ameritek, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ameritek, Inc. have?
Ameritek, Inc. has 17 FDA 510(k) clearances (first 1986, latest 2000), across 15 product codes in 4 review panels.
How long does FDA take to clear Ameritek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ameritek, Inc.'s cleared 510(k)s is 68 days.
What devices does Ameritek, Inc. make?
Its most frequent FDA product codes are DKZ (Enzyme Immunoassay, Amphetamine, 2); JHI (Visual, Pregnancy Hcg, Prescription Use, 2); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Has Ameritek, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ameritek, Inc. Related entities may recall under other names.
Next steps
- See all 17 Ameritek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Ameritek, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.