Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MJZ — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | Binax, Inc. | 2009-09-01 | 259 | 0 |
| K972182 | ABBOTT STREP A CONTROLS | Abbott Diagnostics | 1997-08-13 | 76 | 0 |
| K972129 | CHLAMYDIATROL AG | Blackhawk Biosystems, Inc. | 1997-08-12 | 67 | 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