FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
K Number: K002107
·
Decision Aug 4, 2000
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
39
Applicant Total
14
Review Days
23
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Basic Information
- Device Name
- IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
- K Number
- K002107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scimedx Corp.
- Date Received
- July 12, 2000
- Decision Date
- August 4, 2000
- Product Code
- MVM
- 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 |
|---|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | FDA class 2 | Immunology |
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Other Clearances by Scimedx Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | Jun 25, 2001 | Substantially Equivalent |
| K011082 | TPO IGG ANTIBODY EIA TEST | Jun 6, 2001 | Substantially Equivalent |
| K010625 | EUROSPITAL EU-TTG IGA UMANA | Apr 24, 2001 | Substantially Equivalent |
| K010287 | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA | Mar 16, 2001 | Substantially Equivalent |
| K010289 | SCIMEDX PHASE II MPO IGG ANTIBODY EIA | Mar 7, 2001 | Substantially Equivalent |
| K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM | Oct 19, 2000 | Substantially Equivalent |
| K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM | Oct 19, 2000 | Substantially Equivalent |
| K994379 | EU-TTG IGA ELISA | Feb 18, 2000 | Substantially Equivalent |
| K970198 | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES | Feb 20, 1997 | Substantially Equivalent |
| K962360 | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES | Sep 30, 1996 | Substantially Equivalent |