Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DDX — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
172 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941346 | PLASMINOGEN RID TEST KIT | The Binding Site, Ltd. | 1994-09-09 | 172 | 0 |
| K884766 | BERICHROM(R) PLASMINOGEN | Behring Diagnostics, Inc. | 1989-01-04 | 51 | 0 |
| K864212 | IL TEST 97573-15, PLASMINOGEN ASSAY | Instrumentation Laboratory CO | 1986-12-04 | 37 | 0 |
| K854572 | COATEST PLASMINOGEN | Kabivitrum, Inc. | 1986-02-26 | 104 | 0 |
| K850410 | GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY | Warner-Lambert Co. | 1985-05-08 | 93 | 0 |
| K832591 | DIACROM *PLG | Wellcome Diagnostics | 1983-11-21 | 111 | 0 |
| K812625 | ACA PLASMINOGEN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 | 14 | 0 |
| K811777 | HELENA PLASMINOGEN QUIPLATE PROCEDURE | Helena Laboratories | 1981-07-02 | 9 | 0 |
| K781478 | PLASMINOGEN ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-15 | 79 | 0 |
| K772085 | LAS-R HUMAN PLASMINOGEN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 | 81 | 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