K231151
- 510(k) number
- K231151
- Device name
- Kenota 1 Total IgE; Kenota 1 (instrument)
- Applicant
- Kenota, Inc. CA
- Product code
- DGC — Ige, Antigen, Antiserum, Control
- Decision date
- 2024-05-31
- Date received
- 2023-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231151.pdf
Official FDA record: K231151
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.