FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
K Number: K093957
·
Decision Mar 18, 2010
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
4
Applicant Total
9
Review Days
85
Basic Information
- Device Name
- ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- K Number
- K093957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIREBIO DIAGNOSTICS, INC
- Date Received
- December 23, 2009
- Decision Date
- March 18, 2010
- Product Code
- OIU
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OIU), ordered by most recent decision date.
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
FDA 510(k)
FDA Class 2
·Immunology
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
FDA 510(k)
FDA Class 2
·Immunology
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
FDA 510(k)
FDA Class 2
·Immunology
HE4 EIA, MODEL: 404-10 US
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by FUJIREBIO DIAGNOSTICS, INC
| K Number | Device Name | ||
|---|---|---|---|
| K163521 | Lumipulse G LH Calibrators | Jan 12, 2017 | Substantially Equivalent |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | May 21, 2015 | Substantially Equivalent |
| K110641 | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL | May 27, 2011 | Substantially Equivalent |
| K100831 | CYFRA 21-1 EIA MODEL 211-10 | May 26, 2011 | Substantially Equivalent |
| K110436 | FDI GLUCOSE CONTROL SOLUTION FOR AVIVA | Apr 20, 2011 | Substantially Equivalent |
| K103450 | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE | Jan 25, 2011 | Substantially Equivalent |
| K101809 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 | Oct 5, 2010 | Substantially Equivalent |
| K102260 | FDI GLUCOSE CONTROL SOLUTIONS | Sep 24, 2010 | Substantially Equivalent |