Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Products Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corporation | 2006-12-22 | 78 | 0 |
| K060929 | IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 T | Diagnostic Products Corporation | 2006-04-28 | 23 | 0 |
| K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH | Diagnostic Products Corporation | 2006-02-03 | 46 | 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