Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dilab, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
111 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862530 | RAPID AS LATEX | Dilab, Inc. | 1987-04-21 | 293 | 0 |
| K850931 | ALBUMIN | Dilab, Inc. | 1985-06-26 | 111 | 0 |
| K850934 | PHOSPHORUS | Dilab, Inc. | 1985-06-25 | 110 | 0 |
| K850932 | CREATININE | Dilab, Inc. | 1985-06-25 | 110 | 0 |
| K850933 | URIC ACID | Dilab, Inc. | 1985-06-25 | 110 | 0 |
| K850938 | CHOLESTEROL | Dilab, Inc. | 1985-06-25 | 110 | 0 |
| K850936 | TOTAL PROTEINS | Dilab, Inc. | 1985-06-25 | 110 | 0 |
| K850937 | UREA | Dilab, Inc. | 1985-06-10 | 95 | 0 |
| K850930 | GLUCOSE | Dilab, Inc. | 1985-06-10 | 95 | 0 |
| K850935 | CHLORIDE | Dilab, Inc. | 1985-06-10 | 95 | 0 |
| K850929 | CALCIUM | Dilab, Inc. | 1985-06-10 | 95 | 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