FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI-NDNA ANTIBODY TEST KIT
K Number: K864275
·
Decision Dec 15, 1986
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
18
Applicant Total
3
Review Days
47
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Basic Information
- Device Name
- ANTI-NDNA ANTIBODY TEST KIT
- K Number
- K864275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Cappel Diagnostics, Inc.
- Date Received
- October 29, 1986
- Decision Date
- December 15, 1986
- Product Code
- KTL
- 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 |
|---|---|---|---|
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | FDA class 2 | Immunology |
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