Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Diagnostics, Ca. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853140 | MDI QUIK TEST NARCOTICS DRUG SCREEN | Medical Diagnostics, Ca. | 1986-03-03 | 217 | 0 |
| K843900 | FOCUSCOPE UNIVERSAL SYSTEM | Medical Diagnostics, Ca. | 1984-12-06 | 64 | 0 |
| K843343 | MEDICA IIF-ANTI-THYROID ANTIBODY TEST | Medical Diagnostics, Ca. | 1984-10-22 | 56 | 0 |
| K831100 | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | Medical Diagnostics, Ca. | 1983-05-04 | 29 | 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