FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
EBV EA-D IGG ELISA KIT, MODEL EBG-100
K Number: K021793
·
Decision Sep 27, 2002
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
55
Applicant Total
4
Review Days
119
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Basic Information
- Device Name
- EBV EA-D IGG ELISA KIT, MODEL EBG-100
- K Number
- K021793
- 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
- May 31, 2002
- Decision Date
- September 27, 2002
- Product Code
- LSE
- 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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | FDA class 1 | Microbiology |
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