Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Modern Diagnostics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
60 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853269 | PREGNA/TEST | Modern Diagnostics, Inc. | 1985-10-03 | 59 | 0 |
| K853258 | BETA-HCG MICROTITER PREGNANCY TEST | Modern Diagnostics, Inc. | 1985-10-01 | 60 | 0 |
| K853006 | HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY | Modern Diagnostics, Inc. | 1985-09-04 | 50 | 0 |
| K852840 | ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST | Modern Diagnostics, Inc. | 1985-08-01 | 27 | 0 |
| K851369 | ANTINUCLEAR ANTIBODY TEST KIT | Modern Diagnostics, Inc. | 1985-05-15 | 40 | 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