HE4 EIA, MODEL: 404-10 US
FDA 510(k) clearance K072939 · decided 2008-06-09
Clearance details
- K-number
- K072939
- Device name
- HE4 EIA, MODEL: 404-10 US
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-17
- Decision date
- 2008-06-09
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- OIU
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (K151378) | Fujirebio Diagnostics,Inc. | 2015-11-24 |
| ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 (K112624) | Roche Diagnostics | 2012-09-10 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL (K103676) | Fujirebio Diagnostics,Inc. | 2011-07-19 |
| ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, (K093957) | Fujirebio Diagnostics,Inc. | 2010-03-18 |
Recalls involving this device
No recalls on record reference this clearance.