Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diazyme Laboratories, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
253 daysmedian FDA review time
290 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | 2026-06-16 | 266 | 0 |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Ass | Diazyme Laboratories, Inc. | 2026-04-24 | 270 | 0 |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Huma | Diazyme Laboratories, Inc. | 2025-12-19 | 80 | 0 |
| K243462 | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | 2025-08-01 | 266 | 0 |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human La | Diazyme Laboratories, Inc. | 2022-09-08 | 468 | 0 |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human La | Diazyme Laboratories, Inc. | 2022-08-04 | 212 | 0 |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite | Diazyme Laboratories, Inc. | 2021-12-13 | 150 | 0 |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | 2021-08-06 | 290 | 0 |
| K180209 | Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. | 2018-10-04 | 253 | 0 |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human La | Diazyme Laboratories, Inc. | 2018-06-26 | 25 | 0 |
| K180074 | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | 2018-03-22 | 71 | 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