AvertD and AvertD Buccal Sample Collection Kit
FDA premarket approval P230032/S001 · decided 2024-02-16
Approval details
- PMA number
- P230032
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- 2024-01-18
- Decision date
- 2024-02-16
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- QZH
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230032.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INFINITI SYSTEM (K060564) | AutoGenomics, Inc. | 2007-02-07 |