FDA Product Code
FDA Product Code DDX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5715
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K941346 | PLASMINOGEN RID TEST KIT | The Binding Site, Ltd. | 1994-09-09 | Traditional | PDF ↗ |
| K884766 | BERICHROM(R) PLASMINOGEN | Behring Diagnostics, Inc. | 1989-01-04 | Traditional | PDF ↗ |
| K864212 | IL TEST 97573-15, PLASMINOGEN ASSAY | Instrumentation Laboratory CO | 1986-12-04 | Traditional | PDF ↗ |
| K854572 | COATEST PLASMINOGEN | Kabivitrum, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K850410 | GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY | Warner-Lambert Co. | 1985-05-08 | Traditional | PDF ↗ |
| K832591 | DIACROM *PLG | Wellcome Diagnostics | 1983-11-21 | Traditional | PDF ↗ |
| K812625 | ACA PLASMINOGEN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 | Traditional | PDF ↗ |
| K811777 | HELENA PLASMINOGEN QUIPLATE PROCEDURE | Helena Laboratories | 1981-07-02 | Traditional | PDF ↗ |
| K781478 | PLASMINOGEN ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-15 | Traditional | PDF ↗ |
| K772085 | LAS-R HUMAN PLASMINOGEN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 | Traditional | PDF ↗ |
Product code DDX · Class I · Immunology. Data: openFDA.