Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnon Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
175 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860967 | VIRTRAN VIRAL TRANSPORTER (MODIFIED) | Diagnon Corp. | 1986-04-04 | 25 | 0 |
| K851635 | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST | Diagnon Corp. | 1985-10-10 | 175 | 0 |
| K851377 | DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA | Diagnon Corp. | 1985-08-21 | 135 | 0 |
| K851378 | VIRTRAN VIRAL TRANPORTER | Diagnon Corp. | 1985-06-21 | 74 | 0 |
| K841302 | DIAGNON FOLATE 125I RIA KIT | Diagnon Corp. | 1984-06-22 | 84 | 0 |
| K832717 | DIAGNON B12 57CO RIA KIT | Diagnon Corp. | 1983-12-08 | 118 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda