FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERAQUEST EBV EA-D IGG TEST
K Number: K091260
·
Decision Jun 8, 2009
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
55
Applicant Total
25
Review Days
40
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Basic Information
- Device Name
- SERAQUEST EBV EA-D IGG TEST
- K Number
- K091260
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quest Intl., Inc.
- Date Received
- April 29, 2009
- Decision Date
- June 8, 2009
- Product Code
- LSE
- 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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | FDA class 1 | Microbiology |
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Other Clearances by Quest Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K982281 | SERAQUEST RUBELLA IGM | Oct 16, 1998 | Substantially Equivalent |