FDA Product Code
FDA Product Code OSX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1117
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | Fujirebio Diagnostics,Inc. | 2014-12-23 | Traditional | PDF ↗ |
| K093758 | BGM GALECTIN -3 | Bg Medicine, Inc. | 2010-11-17 | Traditional | PDF ↗ |
Product code OSX · Class II · Clinical Chemistry. Data: openFDA.