Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dako Diagnostics , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
216 daysmedian FDA review time
707 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981226 | IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMA | Dako Diagnostics , Ltd. | 1998-09-28 | 188 | 0 |
| K973954 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | 1997-12-22 | 74 | 0 |
| K962037 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | 1996-12-26 | 216 | 0 |
| K940564 | IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION | Dako Diagnostics , Ltd. | 1996-01-11 | 707 | 0 |
| K943557 | IMAGEN | Dako Diagnostics , Ltd. | 1995-01-09 | 171 | 0 |
| K932384 | IDEIA(TM) ROTAVIRUS | Dako Diagnostics , Ltd. | 1993-12-27 | 224 | 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