FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI NUCLEAR ANTIBODY TEST
K Number: K791995
·
Decision Oct 30, 1979
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- ANTI NUCLEAR ANTIBODY TEST
- K Number
- K791995
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Meda Stat Diagnostics, Inc.
- Date Received
- October 3, 1979
- Decision Date
- October 30, 1979
- Product Code
- DHN
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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