FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MERIDIAN EBNA TEST KIT
K Number: K925690
·
Decision Oct 12, 1993
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
26
Applicant Total
4
Review Days
334
Basic Information
- Device Name
- MERIDIAN EBNA TEST KIT
- K Number
- K925690
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- FULLER LABORATORIES, INC.
- Date Received
- November 12, 1992
- Decision Date
- October 12, 1993
- Product Code
- LLM
- 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 |
|---|---|---|---|
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | FDA class 1 | Microbiology |
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