FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K Number: K003069
·
Decision Nov 27, 2000
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
93
Applicant Total
25
Review Days
56
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Basic Information
- Device Name
- ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
- K Number
- K003069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quest Intl., Inc.
- Date Received
- October 2, 2000
- Decision Date
- November 27, 2000
- Product Code
- MID
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | FDA class 2 | Immunology |
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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 |
| 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 |