Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MZV — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200865 | Piccolo Potassium Test System | Abaxis, Inc. | 2021-10-20 | 567 | 0 |
| K091455 | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL D | Diazyme Laboratories | 2009-08-14 | 88 | 0 |
| K053566 | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ | Diazyme Laboratories | 2006-02-15 | 55 | 0 |
| K042191 | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT | Diazyme Laboratories | 2004-10-29 | 78 | 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