FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERAQUEST MUMPS IGG
K Number: K980059
·
Decision Apr 23, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
7
Applicant Total
25
Review Days
106
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Basic Information
- Device Name
- SERAQUEST MUMPS IGG
- K Number
- K980059
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quest Intl., Inc.
- Date Received
- January 7, 1998
- Decision Date
- April 23, 1998
- Product Code
- LJY
- 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 |
|---|---|---|---|
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJY), ordered by most recent decision date.
MUMPS IGG ELISA TEST SYSTEM
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MUMPS IGG ELISA TESTY
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MUMPS IGG TEST
FDA 510(k)
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MUMPS STAT
FDA 510(k)
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VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
FDA 510(k)
FDA Class 1
·Microbiology
PHARMACIA MUMPS IGG ELISA
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Quest Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091260 | SERAQUEST EBV EA-D IGG TEST | Jun 8, 2009 | Substantially Equivalent |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | Jan 16, 2004 | Substantially Equivalent |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | Jan 15, 2004 | Substantially Equivalent |
| K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | Feb 6, 2003 | Substantially Equivalent |
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | Jan 6, 2003 | Substantially Equivalent |
| K003069 | ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM | Nov 27, 2000 | Substantially Equivalent |
| K991975 | SERAQUEST EB NA IGG | Nov 2, 1999 | Substantially Equivalent |
| K990410 | SERAQUEST EB VCA IGG | Oct 28, 1999 | Substantially Equivalent |
| K990977 | SERAQUEST EB VAC IGM | Oct 6, 1999 | Substantially Equivalent |
| K982485 | SERAQUEST CMV IGM | Jan 13, 1999 | Substantially Equivalent |