FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIA SCL-70S IMMUNOASSAY
K Number: K140493
·
Decision Oct 30, 2014
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
1
Review Days
245
Basic Information
- Device Name
- ELIA SCL-70S IMMUNOASSAY
- K Number
- K140493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHADIA GMBH
- Date Received
- February 27, 2014
- Decision Date
- October 30, 2014
- Product Code
- LJM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJM), ordered by most recent decision date.
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
ImmuLisa Enhanced Centromere Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH CENTROMERE
FDA 510(k)
FDA Class 2
·Immunology
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
ANA SCREEN ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
FDA 510(k)
FDA Class 2
·Immunology