FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
K Number: K900974
·
Decision Apr 16, 1990
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
7
Review Days
45
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Basic Information
- Device Name
- INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
- K Number
- K900974
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Stellar Bio Systems, Inc.
- Date Received
- March 2, 1990
- Decision Date
- April 16, 1990
- 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
FDA 510(k)
FDA Class 1
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BION EBV-G (VCA) TEST SYSTEM
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FDA Class 1
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EBV EARLY ANTIGEN (R+D)
FDA 510(k)
FDA Class 1
·Microbiology
EBV IGM TEST
FDA 510(k)
FDA Class 1
·Microbiology
EBV-M KIT
FDA 510(k)
FDA Class 1
·Microbiology
EBV-VCA ANTIBODY ASSAY KIT
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Stellar Bio Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | Dec 22, 1999 | Substantially Equivalent |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | Apr 21, 1999 | Substantially Equivalent |
| K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY | Apr 21, 1999 | Substantially Equivalent |
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | Feb 19, 1992 | Substantially Equivalent |
| K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | Nov 7, 1991 | Substantially Equivalent |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | Dec 5, 1988 | Substantially Equivalent |