FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EBNA ACIF ASSAY KIT
K Number: K871298
·
Decision Jun 25, 1987
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
26
Applicant Total
8
Review Days
86
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Basic Information
- Device Name
- EBNA ACIF ASSAY KIT
- K Number
- K871298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Granbio, Inc.
- Date Received
- March 31, 1987
- Decision Date
- June 25, 1987
- Product Code
- LLM
- 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 |
|---|---|---|---|
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | FDA class 1 | Microbiology |
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Other Clearances by Granbio, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | Feb 15, 1996 | Substantially Equivalent |
| K934774 | UNKNOWN | Apr 20, 1994 | Substantially Equivalent |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | Sep 12, 1990 | Substantially Equivalent |
| K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | Sep 12, 1990 | Substantially Equivalent |
| K881617 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY | Jun 7, 1988 | Substantially Equivalent |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Feb 2, 1987 | Substantially Equivalent |
| K864604 | EBV VCA IGM ANTIBODY ASSAY KIT | Feb 2, 1987 | Substantially Equivalent |