Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interlab S.R.L. — 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) |
|---|---|---|---|---|---|
| K053571 | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MI | Interlab S.R.L. | 2006-06-30 | 190 | 0 |
| K040146 | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2004-05-04 | 103 | 0 |
| K032862 | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2004-02-03 | 144 | 0 |
| K033187 | INTERLAB IMMUNOFIXATION TEST(S) | Interlab S.R.L. | 2003-11-19 | 49 | 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