510(k) K180553
K180553 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "VERIFY Spore Test Strip for S40 Sterilant". The FDA issued a decision of Substantially Equivalent on May 29, 2018. The device falls under product code OVY (Liquid Chemical Processing System), a Class II device regulated under 21 CFR 880.6887. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2018
- Date Received
- March 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Liquid Chemical Processing System
- Device Class
- Class II
- Regulation Number
- 880.6887
- Review Panel
- HO
- Submission Type
The liquid chemical processing system is intended as a standard method for routine monitoring.