FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
K Number: K901156
·
Decision Sep 12, 1990
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
8
Review Days
183
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Basic Information
- Device Name
- EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
- K Number
- K901156
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Granbio, Inc.
- Date Received
- March 13, 1990
- Decision Date
- September 12, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNP), ordered by most recent decision date.
EBV V VCA IGM ELISA KIT MODEL# EBM-200
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EBV-EBNA IGG ELISA KIT, MODEL EBG-100
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EBV-VCA IGG ELISA TEST, MODEL EBG-100
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IS EBV-EA-D IGG ELISA TEST SYSTEM
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IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
FDA 510(k)
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SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| 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 |
| K871298 | EBNA ACIF ASSAY KIT | Jun 25, 1987 | 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 |