Drial Consultants, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Drial Consultants, Inc.” (first 1997, latest 1998), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 75 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 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
- Clinical Toxicology (13)
Most recent Drial Consultants, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973269 | QUIKSTRIP ONE STEP BENZODIAZEPINE TEST | JXM | 1998-02-25 | 180 |
| K973326 | QUIKPAC II ONE STEP BENZODIAZEPINE TEST | JXM | 1998-02-24 | 173 |
| K973047 | ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST | DIS | 1997-10-02 | 48 |
| K972059 | QUIKPAC II ONE STEP COCAINE TEST | DIO | 1997-08-28 | 87 |
| K972571 | QUIKSTRIP ONE STEP OPIATES TEST | DJG | 1997-08-20 | 41 |
| K972405 | QUIKPAC II ONE STEP OPIATE TEST | DJG | 1997-08-08 | 43 |
| K971926 | QUIKSTRIP ONE STEP COCAINE TEST | DIO | 1997-07-14 | 48 |
| K970395 | QUIKSTRIP ONE STEP METHAMPHETAMINE | DKZ | 1997-06-26 | 143 |
| K971218 | QUIKSTRIP ONE STEP AMPHETAMINE TEST | DKZ | 1997-05-30 | 58 |
| K971109 | QUIKPAC II ONE STEP AMPHETAMINE TEST | DKZ | 1997-05-14 | 49 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Drial Consultants, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Drial Consultants, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Drial Consultants, Inc.” (first 1997, latest 1998), across 6 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 Drial Consultants, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Drial Consultants, Inc. is 75 days.
Which FDA product codes appear under Drial Consultants, 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 13 Drial Consultants, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Drial Consultants, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.