FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENA PROFILE ELISA TEST SYSTEM
K Number: K993839
·
Decision Jan 12, 2000
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
11
Review Days
61
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Basic Information
- Device Name
- ENA PROFILE ELISA TEST SYSTEM
- K Number
- K993839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trinity Biotech USA
- Date Received
- November 12, 1999
- Decision Date
- January 12, 2000
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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