MID

System, Test, Anticardiolipin Immunological

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): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 94 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-12-17.

Number	Decision date	Applicant	Device name	Summary
K223093	2024-12-17	Inova Diagnostics, Inc.	Aptiva APS IgG Reagent; Aptiva APS IgM Reagent	PDF

1 summaries are archived here for direct download.

Official FDA classification page: MID

Classification and pathway per current FDA publications. Data from openFDA (CC0).