K243979
- 510(k) number
- K243979
- Device name
- Aptiva APS IgA Reagent
- Applicant
- Inova Diagnostics, Inc. CA · US
- Product code
- MSV — System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi
- Decision date
- 2026-02-06
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243979.pdf
Official FDA record: K243979
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.