510(k) K093957
- Device
- ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- Applicant
- FUJIREBIO DIAGNOSTICS, INC
- 510(k) number
- K093957
- Product code
- OIU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-18
- Date received
- 2009-12-23
- Regulation
- 866.6010
- Classification name
- Test, Epithelial Ovarian Tumor Associated Antigen (he4)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STACEY DOLAN
- Address
- 201 Great Valley Pkwy. Malvern PA US 19355 19355
FDA Registration Numbers#
- 9610126
- 3002809144
- 2032839
- 2521625
- 3005333358
Source Documents#
Other 510(k) Records For Product Code OIU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | Fujirebio Diagnostics,Inc. | 2015-11-24 |
| K112624 | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 | Roche Diagnostics | 2012-09-10 |
| K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | Fujirebio Diagnostics,Inc. | 2011-07-19 |
| K072939 | HE4 EIA, MODEL: 404-10 US | Fujirebio Diagnostics,Inc. | 2008-06-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary