510(k) K181442
K181442 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "VERIFY Assert Self-Contained Biological Indicator". The FDA issued a decision of Substantially Equivalent on June 13, 2018. The device falls under product code OWP (Biological Sterilization Process Indicator With Recombinant-Dna Plasmid), a Class II device regulated under 21 CFR 880.2805. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2018
- Date Received
- June 1, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
- Device Class
- Class II
- Regulation Number
- 880.2805
- Review Panel
- HO
- Submission Type
A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.