AvertD and AvertD Buccal Sample Collection Kit
FDA premarket approval P230032/S002 · decided 2024-11-07
Approval details
- PMA number
- P230032
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AvertD and AvertD Buccal Sample Collection Kit
- Generic name
- Opioid use disorder genetic risk variant detection system and collection kit
- Applicant
- AutoGenomics, Inc.
- Date received
- 2024-05-17
- Decision date
- 2024-11-07
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- QZH
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval for the addition of the INFINITI High-Throughput System (HTS) for use in analyzing samples with the AvertD test
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INFINITI SYSTEM (K060564) | AutoGenomics, Inc. | 2007-02-07 |