FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERAQUEST ANTI-DSDNA
K Number: K980391
·
Decision Apr 24, 1998
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
25
Review Days
81
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SERAQUEST ANTI-DSDNA
- K Number
- K980391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quest Intl., Inc.
- Date Received
- February 2, 1998
- Decision Date
- April 24, 1998
- Product Code
- LRM
- 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 |
|---|---|---|---|
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRM), ordered by most recent decision date.
IMMULISA DSDNA ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
VARELISA SSDNA ANTIBODIES, MODEL 14896
FDA 510(k)
FDA Class 2
·Immunology
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
MDI DS-DNA TEST
FDA 510(k)
FDA Class 2
·Immunology
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 |