FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EBV VCA IGM ANTIBODY ASSAY KIT
K Number: K864604
·
Decision Feb 2, 1987
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
22
Applicant Total
8
Review Days
70
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Basic Information
- Device Name
- EBV VCA IGM ANTIBODY ASSAY KIT
- K Number
- K864604
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Granbio, Inc.
- Date Received
- November 24, 1986
- Decision Date
- February 2, 1987
- Product Code
- LJN
- 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 |
|---|---|---|---|
| LJN | Antibody Igm, If, Epstein-Barr Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJN), ordered by most recent decision date.
BIOPLEX 2200 EBV IGM KIT
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FDA Class 1
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PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
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FDA Class 1
·Microbiology
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
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FDA Class 1
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MODIFICATION TO SERAQUEST VCA IGM
FDA 510(k)
FDA Class 1
·Microbiology
SERAQUEST EB VAC IGM
FDA 510(k)
FDA Class 1
·Microbiology
COPALIS EBV-M ANTIBODY ASSAY
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 |
| 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 |
| K871298 | EBNA ACIF ASSAY KIT | Jun 25, 1987 | Substantially Equivalent |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Feb 2, 1987 | Substantially Equivalent |