MID
- Product code
- MID
- Device name
- System, Test, Anticardiolipin Immunological
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 94
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K223093 | 2024-12-17 | Inova Diagnostics, Inc. | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent |
Official FDA classification page: MID
Classification and pathway per current FDA publications. Data from openFDA (CC0).