510(k) DEN230085
DEN230085 is an FDA 510(k) premarket notification submitted by Steris for the device "VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator". The FDA issued a decision of De Novo Granted on November 12, 2024. The device falls under product code SDC (Qualitative Cleaning Process Protein Indicator), a Class II device regulated under 21 CFR 880.6930. Steris has at least 10 other 510(k) clearances on record.
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.