FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EBV-VCA IGM ELISA
K Number: K915348
·
Decision Feb 14, 1992
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
22
Applicant Total
7
Review Days
80
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Basic Information
- Device Name
- EBV-VCA IGM ELISA
- K Number
- K915348
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pharmacia Diagnostics, Inc.
- Date Received
- November 26, 1991
- Decision Date
- February 14, 1992
- 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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PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
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ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
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MODIFICATION TO SERAQUEST VCA IGM
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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 Pharmacia Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921011 | PHARMACIA CMV IGM ELISA | Jul 27, 1992 | Substantially Equivalent |
| K920702 | TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO | Jul 8, 1992 | Substantially Equivalent |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | Jan 27, 1992 | Substantially Equivalent |
| K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT | Jun 25, 1991 | Substantially Equivalent |
| K902793 | RUBELLA IGG | Jul 31, 1990 | Substantially Equivalent |
| K902792 | TOXOPLASMA GONDII IGG | Jul 24, 1990 | Substantially Equivalent |