FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
EBV-VCA IGG ELISA TEST, MODEL EBG-100
K Number: K020706
·
Decision Jun 13, 2002
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
4
Review Days
101
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Basic Information
- Device Name
- EBV-VCA IGG ELISA TEST, MODEL EBG-100
- K Number
- K020706
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pan Bio Pty. , Ltd.
- Date Received
- March 4, 2002
- Decision Date
- June 13, 2002
- Product Code
- GNP
- 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 |
|---|---|---|---|
| GNP | Antiserum, Cf, Epstein-Barr Virus | FDA class 1 | Microbiology |
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