FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL— 510(k) K103676
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K103676 for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL, Substantially Equivalent on 2011-07-19. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code OIU
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code OIU
view all- K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- K093957 — ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- K072939 — HE4 EIA, MODEL: 404-10 US
More clearances from Fujirebio Diagnostics,Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.