510(k) K241456
- Device
- GlutenID Celiac Genetic Health Risk Test
- Applicant
- Targeted Genomics, LLC
- 510(k) number
- K241456
- Product code
- PTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-07
- Date received
- 2024-05-22
- Regulation
- 866.5950
- Classification name
- Genetic Variant Detection And Health Risk Assessment System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Shelly Gunn
- Address
- 5 Mason Irvine CA US 92618 92618
FDA Registration Numbers
- 3018077536
- 3015489159
- 3003436513
- 3035380687
- 3007699459
- 3004597845
- 3038181305
- 3006413195
Source Documents
510(k) summary PDF not indicated by FDA
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| K221420 | AlphaID At Home Genetic Health Risk Service | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 |
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimers disease | Helix Opco, LLC | 2020-12-23 |
| K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | 2020-08-13 |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23AndMe, Inc. | 2017-04-06 |