DDX
10 FDA 510(k) clearances · Product code
81 daysmedian time to decision
172 days90th percentile
10clearances measured
FDA profile
- Official device name
- Plasminogen, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5715
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PLASMINOGEN RID TEST KIT (K941346) | The Binding Site, Ltd. | 1994-09-09 |
| BERICHROM(R) PLASMINOGEN (K884766) | Behring Diagnostics, Inc. | 1989-01-04 |
| IL TEST 97573-15, PLASMINOGEN ASSAY (K864212) | Instrumentation Laboratory CO | 1986-12-04 |
| COATEST PLASMINOGEN (K854572) | Kabivitrum, Inc. | 1986-02-26 |
| GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (K850410) | Warner-Lambert Co. | 1985-05-08 |
| DIACROM *PLG (K832591) | Wellcome Diagnostics | 1983-11-21 |
| ACA PLASMINOGEN TEST PACK (K812625) | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 |
| HELENA PLASMINOGEN QUIPLATE PROCEDURE (K811777) | Helena Laboratories | 1981-07-02 |
| PLASMINOGEN ASSAY (K781478) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-15 |
| LAS-R HUMAN PLASMINOGEN TEST (K772085) | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 |
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Every clearance here is in the API, with alerts when new ones post.