FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI-DS/N-DNA TEST KIT
K Number: K801960
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
8
Review Days
52
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Basic Information
- Device Name
- ANTI-DS/N-DNA TEST KIT
- K Number
- K801960
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Immuno-Diagnostic Products, Inc.
- Date Received
- August 19, 1980
- Decision Date
- October 10, 1980
- Product Code
- DBL
- 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 |
|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Immuno-Diagnostic Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Apr 24, 1986 | Substantially Equivalent |
| K811021 | HERPES | Nov 5, 1981 | Substantially Equivalent |
| K811562 | TOXOPLASMOSIS TEST KIT | Jul 16, 1981 | Substantially Equivalent |
| K811022 | ANA TEST KIT | Apr 23, 1981 | Substantially Equivalent |
| K801959 | FTA-ABS TEST | Oct 23, 1980 | Substantially Equivalent |
| K801963 | CMV TEST KIT | Oct 23, 1980 | Substantially Equivalent |
| K801961 | RF-II TEST KIT | Oct 10, 1980 | Substantially Equivalent |