Gilford: FDA clearances and approvals
Gilford has 10 FDA 510(k) clearances (first 1981, latest 1985), across 8 product codes in 3 review panels. Median 510(k) review time: 31 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 | 3 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 1 | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 1 |
Review panels
- Immunology (6)
- Clinical Chemistry (3)
- Microbiology (1)
Most recent Gilford 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853469 | GILFORD IMMUNOGLOBULIN M REAGENT | DFT | 1985-09-16 | 28 |
| K853468 | GILFORD C4 COMPLEMENT REAGENT | DBI | 1985-09-16 | 28 |
| K853467 | GILFORD IMMUNOGLOBULIN A REAGENT | CZP | 1985-09-16 | 28 |
| K853466 | GILFORD C3 COMPLEMENT REAGENT | CZW | 1985-09-16 | 28 |
| K853465 | GILFORD IMMUNOGLOBULIN G REAGENT | DEW | 1985-09-16 | 28 |
| K851202 | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | DAK | 1985-04-29 | 34 |
| K842500 | DATA MGMT. SYSTEM | JJE | 1984-08-16 | 51 |
| K840120 | ADVANTAGE | JJE | 1984-03-23 | 72 |
| K833067 | IMPACT 400 #1447X2 | JJE | 1983-12-08 | 91 |
| K812787 | EIA RUBELLA | LFX | 1981-11-27 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Gilford.
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 have?
Gilford has 10 FDA 510(k) clearances (first 1981, latest 1985), across 8 product codes in 3 review panels.
How long does FDA take to clear Gilford's 510(k)s?
The median time from FDA receipt to decision across Gilford's cleared 510(k)s is 31 days.
What devices does Gilford make?
Its most frequent FDA product codes are JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 3); CZP (Iga, Antigen, Antiserum, Control, 1); CZW (Complement C3, Antigen, Antiserum, Control, 1).
Has Gilford had device recalls?
openFDA lists no recalls under a recalling firm name matching Gilford. Related entities may recall under other names.
Next steps
- See all 10 Gilford clearances with predicates and recalls
- Run predicate analysis for product code JJE, Gilford'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.