510(k) DEN210056
- Device
- Procise IFX
- Applicant
- Procisedx, Inc.
- 510(k) number
- DEN210056
- Product code
- QXT
- Decision
- Unknown (DENG)
- Decision date
- 2023-09-29
- Date received
- 2021-12-08
- Regulation
- 862.3115
- Classification name
- Infliximab Test System
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kurtis R. Bray
- Address
- 9449 Carroll Park Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 2431980
- 3026565854
- 2032839
Source Documents#
510(k) summary PDF not indicated by FDA