Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agen Biomedical , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
343 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 | Agen Biomedical , Ltd. | 1999-12-14 | 75 | 1 |
| K974596 | DIMERTEST LATEX ASSAY | Agen Biomedical , Ltd. | 1998-05-26 | 168 | 0 |
| K945642 | AGEN DIMERTEST GOLD EIA | Agen Biomedical , Ltd. | 1995-10-25 | 343 | 0 |
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | Agen Biomedical , Ltd. | 1991-04-12 | 116 | 0 |
| K890189 | AGEN DIMERTEST EIA | Agen Biomedical , Ltd. | 1989-03-03 | 45 | 0 |
| K882944 | DIMERTEST(R) LATEX | Agen Biomedical , Ltd. | 1988-08-17 | 34 | 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