510(k) K231746
- Device
- VERIFY Spore Test Strip for S40 Sterilant Concentrate
- Applicant
- STERIS Corporation
- 510(k) number
- K231746
- Product code
- OVY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-11
- Date received
- 2023-06-15
- Regulation
- 880.6887
- Classification name
- Liquid Chemical Processing System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Gregory Land
- Address
- 5960 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers
- 3004080920
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON