FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K Number: K021482
·
Decision Jul 30, 2002
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
126
Review Days
83
Basic Information
- Device Name
- QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
- K Number
- K021482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INOVA DIAGNOSTICS, INC.
- Date Received
- May 8, 2002
- Decision Date
- July 30, 2002
- Product Code
- NIY
- 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 |
|---|---|---|---|
| NIY | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NIY), ordered by most recent decision date.
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FDA 510(k)
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FDA 510(k)
FDA Class 2
·Immunology
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