K241456
- 510(k) number
- K241456
- Device name
- GlutenID Celiac Genetic Health Risk Test
- Applicant
- Targeted Genomics, LLC CA · US
- Product code
- PTA — Genetic Variant Detection And Health Risk Assessment
- Decision date
- 2025-01-07
- Date received
- 2024-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241456
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.