K213403
- 510(k) number
- K213403
- Device name
- Aptiva CTD Essential Reagent
- Applicant
- Inova Diagnostics, Inc. CA · US
- Product code
- LLL — Extractable Antinuclear Antibody, Antigen And Contro
- Decision date
- 2023-09-29
- Date received
- 2021-10-18
- 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: K213403.pdf
Official FDA record: K213403
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.