FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EBV-M KIT
K Number: K822985
·
Decision Dec 3, 1982
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
15
Review Days
52
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Basic Information
- Device Name
- EBV-M KIT
- K Number
- K822985
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Litton Bionetics
- Date Received
- October 12, 1982
- Decision Date
- December 3, 1982
- Product Code
- JRY
- 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 |
|---|---|---|---|
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRY), ordered by most recent decision date.
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
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INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
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BION EBV-G (VCA) TEST SYSTEM
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EBV IGM TEST
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EBV-VCA ANTIBODY ASSAY KIT
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Litton Bionetics
| K Number | Device Name | ||
|---|---|---|---|
| K840417 | EBNA ACIF KIT | Dec 27, 1984 | Substantially Equivalent |
| K834443 | ROTAVIRUS BIO-ENZABEAD SCREEN KIT | Mar 16, 1984 | Substantially Equivalent |
| K831343 | CMV RQ BIO-ENZABEAD KIT | Aug 8, 1983 | Substantially Equivalent |
| K821804 | RUBELLA RQ BIO-ENZABEAD KIT | Sep 14, 1982 | Substantially Equivalent |
| K801720 | TOXO BIO-BEAD TITRATION KIT | Sep 16, 1980 | Substantially Equivalent |
| K801721 | HSV BIO-BEAD TITRATION KIT | Sep 16, 1980 | Substantially Equivalent |
| K801722 | CMV BIO-BEAD TITRATION KIT | Sep 16, 1980 | Substantially Equivalent |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | Jun 30, 1980 | Substantially Equivalent |
| K791611 | TOXO BIO-BEAD SCREEN KIT | Nov 13, 1979 | Substantially Equivalent |
| K791610 | RUBELLA BIO-BEAD SCREEN KIT | Nov 13, 1979 | Substantially Equivalent |