FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA LITE GLIADIN IGA II
K Number: K052143
·
Decision Oct 4, 2005
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
41
Applicant Total
138
Review Days
57
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Basic Information
- Device Name
- QUANTA LITE GLIADIN IGA II
- K Number
- K052143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- August 8, 2005
- Decision Date
- October 4, 2005
- Product Code
- MST
- 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 |
|---|---|---|---|
| MST | Antibodies, Gliadin | FDA class 2 | Immunology |
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