FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EBV(EPSTEIN-BARR VIRUS) TEST KIT
K Number: K854207
·
Decision Apr 24, 1986
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
8
Review Days
190
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Basic Information
- Device Name
- EBV(EPSTEIN-BARR VIRUS) TEST KIT
- K Number
- K854207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Immuno-Diagnostic Products, Inc.
- Date Received
- October 16, 1985
- Decision Date
- April 24, 1986
- Product Code
- GNP
- 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 |
|---|---|---|---|
| GNP | Antiserum, Cf, Epstein-Barr Virus | FDA class 1 | Microbiology |
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EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
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Other Clearances by Immuno-Diagnostic Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K801960 | ANTI-DS/N-DNA TEST KIT | Oct 10, 1980 | Substantially Equivalent |
| K801961 | RF-II TEST KIT | Oct 10, 1980 | Substantially Equivalent |