Diagnon Corp.: FDA clearances and approvals
Diagnon Corp. has 6 FDA 510(k) clearances (first 1983, latest 1986), across 5 product codes in 2 review panels. Median 510(k) review time: 101 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | 2 | 2 |
| CGN | Acid, Folic, Radioimmunoassay | 1 | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 1 |
| JSN | Culture Media, Propagating Transport | 1 | 1 |
| LIO | Device, Specimen Collection | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Microbiology (3)
Most recent Diagnon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860967 | VIRTRAN VIRAL TRANSPORTER (MODIFIED) | JSN | 1986-04-04 | 25 |
| K851635 | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST | GQL | 1985-10-10 | 175 |
| K851377 | DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA | CDD | 1985-08-21 | 135 |
| K851378 | VIRTRAN VIRAL TRANPORTER | LIO | 1985-06-21 | 74 |
| K841302 | DIAGNON FOLATE 125I RIA KIT | CGN | 1984-06-22 | 84 |
| K832717 | DIAGNON B12 57CO RIA KIT | CDD | 1983-12-08 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Diagnon Corp..
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 Diagnon Corp. have?
Diagnon Corp. has 6 FDA 510(k) clearances (first 1983, latest 1986), across 5 product codes in 2 review panels.
How long does FDA take to clear Diagnon Corp.'s 510(k)s?
The median time from FDA receipt to decision across Diagnon Corp.'s cleared 510(k)s is 101 days.
What devices does Diagnon Corp. make?
Its most frequent FDA product codes are CDD (Radioassay, Vitamin B12, 2); CGN (Acid, Folic, Radioimmunoassay, 1); GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2, 1).
Has Diagnon Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Diagnon Corp. Related entities may recall under other names.
Next steps
- See all 6 Diagnon Corp. clearances with predicates and recalls
- Run predicate analysis for product code CDD, Diagnon Corp.'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.