Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Diagnostica, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
426 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080069 | DIMERTEST | American Diagnostica, Inc. | 2008-02-13 | 34 | 0 |
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 | American Diagnostica, Inc. | 2007-08-15 | 285 | 2 |
| K052124 | ACTICLOT, MODEL 824 | American Diagnostica, Inc. | 2005-10-17 | 73 | 1 |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | American Diagnostica, Inc. | 2002-04-16 | 162 | 0 |
| K013492 | IMUBIND TPA ELISA, MODEL 860 | American Diagnostica, Inc. | 2002-03-13 | 142 | 0 |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | American Diagnostica, Inc. | 2002-03-08 | 154 | 0 |
| K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | American Diagnostica, Inc. | 2002-03-07 | 167 | 1 |
| K012386 | ACTICLOT PROTEIN S, MODEL 843L | American Diagnostica, Inc. | 2001-09-14 | 49 | 0 |
| K940490 | DV TEST AND DVV CONFIRM | American Diagnostica, Inc. | 1995-04-05 | 426 | 0 |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORM | American Diagnostica, Inc. | 1994-09-19 | 322 | 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