510(k) DEN220023
- Device
- Procise ADL
- Applicant
- Procisedx, Inc.
- 510(k) number
- DEN220023
- Product code
- QYD
- Decision
- Unknown (DENG)
- Decision date
- 2023-09-29
- Date received
- 2022-04-04
- Regulation
- 862.3115
- Classification name
- Adalimumab Assay
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kurt Bray
- Address
- 9449 Carroll Park Dr. San Diego CA US 92121 92121
FDA Registration Numbers
- 2032839
- 2431980
- 3026565854
Source Documents
510(k) summary PDF not indicated by FDA