510(k) DEN230085
- Device
- VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
- Applicant
- Steris
- 510(k) number
- DEN230085
- Product code
- SDC
- Decision
- Unknown (DENG)
- Decision date
- 2024-11-12
- Date received
- 2023-12-18
- Regulation
- 880.6930
- Classification name
- Qualitative Cleaning Process Protein Indicator
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Anthony Piotrkowski
- Address
- 5960 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 3003950207
- 3004080920
Source Documents#
510(k) summary PDF not indicated by FDA