510(k) DEN230085
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 12, 2024
- Date Received
- December 18, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Qualitative Cleaning Process Protein Indicator
- Device Class
- Class II
- Regulation Number
- 880.6930
- Review Panel
- HO
- Submission Type
A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract.