Gilford Diagnostics: FDA clearances and approvals
Gilford Diagnostics has 50 FDA 510(k) clearances (first 1978, latest 1983), across 32 product codes in 2 review panels. Median 510(k) review time: 25 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 7 | 7 |
| JIS | Calibrator, Primary | 5 | 5 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | 2 |
| JIT | Calibrator, Secondary | 2 | 2 |
| LFR | Glucose Dehydrogenase, Glucose | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
Plus 22 more product codes.
Review panels
Most recent Gilford Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832094 | BILIRUBIN CALIBRATORS & CONTROL | JIT | 1983-08-11 | 44 |
| K831844 | DIRECT BILIRUBIN REAGENT | CIG | 1983-07-18 | 40 |
| K831843 | GILCHEM TOTAL BILIRUBIN REAGENT | CIG | 1983-07-18 | 40 |
| K823709 | TRIGLYCERIDE REAGENT (UV) | CDT | 1983-01-07 | 29 |
| K822739 | AHBD | JMK | 1982-10-18 | 39 |
| K822334 | BILIRUBIN CALIBRATORS | JIT | 1982-09-02 | 29 |
| K822289 | CO2/CI STANDARDS | JIX | 1982-08-24 | 22 |
| K822149 | GILCHEM Y-GT REAGENT | JPZ | 1982-08-12 | 21 |
| K821719 | AMMONIA REAGENT | JIF | 1982-06-24 | 14 |
| K820976 | GIL CHEM MAGNESIUM REAGENT | JGJ | 1982-04-26 | 20 |
40 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gilford Diagnostics.
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 Gilford Diagnostics have?
Gilford Diagnostics has 50 FDA 510(k) clearances (first 1978, latest 1983), across 32 product codes in 2 review panels.
How long does FDA take to clear Gilford Diagnostics's 510(k)s?
The median time from FDA receipt to decision across Gilford Diagnostics's cleared 510(k)s is 25 days.
What devices does Gilford Diagnostics make?
Its most frequent FDA product codes are JIX (Calibrator, Multi-Analyte Mixture, 7); JIS (Calibrator, Primary, 5); CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 3).
Has Gilford Diagnostics had device recalls?
openFDA lists no recalls under a recalling firm name matching Gilford Diagnostics. Related entities may recall under other names.
Next steps
- See all 50 Gilford Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JIX, Gilford Diagnostics'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.