K223093
- 510(k) number
- K223093
- Device name
- Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
- Applicant
- Inova Diagnostics, Inc. CA · US
- Product code
- MID — System, Test, Anticardiolipin Immunological
- Decision date
- 2024-12-17
- Date received
- 2022-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K223093.pdf
Official FDA record: K223093
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.