Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MIU — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
507 daysmedian FDA review time
850 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161947 | Chagas Detect Plus Rapid Test | InBios International, Inc. | 2016-12-16 | 155 | 0 |
| K072732 | ORTHO T. CRUZI ELISA TEST SYSTEM | Ortho-Clinical Diagnostics, Inc. | 2009-04-15 | 567 | 0 |
| K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TES | Wiener Laboratories Saic | 2004-02-11 | 447 | 0 |
| K930272 | HEMAGEN CHAGAS' KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-05-19 | 850 | 0 |
| K933716 | ABBOTT CHAGAS ANTIBODY EIA | Abbott Laboratories | 1994-12-19 | 507 | 0 |
| K911233 | CHAGAS' IGG ELISA TEST | Gull Laboratories, Inc. | 1992-05-04 | 411 | 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