Exigent Diagnostics, Inc.: FDA clearances and approvals
Exigent Diagnostics, Inc. has 9 FDA 510(k) clearances (first 1998, latest 1998), across 9 product codes in 1 review panel. Median 510(k) review time: 36 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JGE | Turbidimetric Method, Globulin | 1 | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 1 |
Review panels
Most recent Exigent Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982118 | CARESIDE ANALYZER | CHH | 1998-07-24 | 51 |
| K981899 | CARESIDE HDL-CHOLESTEROL | LBS | 1998-07-14 | 43 |
| K981183 | CARESIDE GLUCOSE | CGA | 1998-05-07 | 36 |
| K980043 | CARESIDE CREATININE | JFY | 1998-03-30 | 83 |
| K980056 | CARESIDE ANALYZER | JJF | 1998-03-06 | 59 |
| K980057 | CARESIDE BUN | CDQ | 1998-02-05 | 30 |
| K980042 | CARESIDE TOTAL PROTEIN | CEK | 1998-02-04 | 29 |
| K980041 | CARESIDE ALBUMIN | CIX | 1998-02-04 | 29 |
| K980055 | CARESIDE GLOBULIN | JGE | 1998-01-28 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Exigent Diagnostics, 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 Exigent Diagnostics, Inc. have?
Exigent Diagnostics, Inc. has 9 FDA 510(k) clearances (first 1998, latest 1998), across 9 product codes in 1 review panel.
How long does FDA take to clear Exigent Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Exigent Diagnostics, Inc.'s cleared 510(k)s is 36 days.
What devices does Exigent Diagnostics, Inc. make?
Its most frequent FDA product codes are CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CEK (Biuret (Colorimetric), Total Protein, 1); CGA (Glucose Oxidase, Glucose, 1).
Has Exigent Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Exigent Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 9 Exigent Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDQ, Exigent Diagnostics, 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.