Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Diagnostic Laboratories, Ltd. — 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) |
|---|---|---|---|---|---|
| K864811 | ROTA-STAT | Intl. Diagnostic Laboratories, Ltd. | 1987-08-25 | 259 | 0 |
| K864228 | APO B., IMMUNOTURBIDIMETRIC ASSAY | Intl. Diagnostic Laboratories, Ltd. | 1987-03-12 | 135 | 0 |
| K864393 | APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC | Intl. Diagnostic Laboratories, Ltd. | 1987-01-16 | 71 | 0 |
| K843367 | ROTAVIRUS ENZYME IMMUNOASSAY | Intl. Diagnostic Laboratories, Ltd. | 1985-06-13 | 289 | 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