FDA Product Code
FDA Product Code OIU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | Fujirebio Diagnostics,Inc. | 2015-11-24 | Traditional | PDF ↗ |
| K112624 | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 | Roche Diagnostics | 2012-09-10 | Traditional | PDF ↗ |
| K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | Fujirebio Diagnostics,Inc. | 2011-07-19 | Traditional | PDF ↗ |
| K093957 | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, | Fujirebio Diagnostics,Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K072939 | HE4 EIA, MODEL: 404-10 US | Fujirebio Diagnostics,Inc. | 2008-06-09 | Traditional | PDF ↗ |
Product code OIU · Class II · Immunology. Data: openFDA.