FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
WEST NILE VIRUS IGG INDIRECT ELISA
K Number: K041068
·
Decision Oct 20, 2004
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
9
Applicant Total
4
Review Days
177
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Basic Information
- Device Name
- WEST NILE VIRUS IGG INDIRECT ELISA
- K Number
- K041068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3940
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Panbio Limited
- Date Received
- April 26, 2004
- Decision Date
- October 20, 2004
- Product Code
- NOP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| NOP | Elisa, Antibody, West Nile Virus | FDA class 2 | Microbiology |
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