510(k) DEN110006
DEN110006 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR". The FDA issued a decision of De Novo Granted on July 12, 2013. 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
- DENG (De Novo Granted)
- Decision Date
- July 12, 2013
- Date Received
- September 6, 2011
- Clearance Type
- Post-NSE
- 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.