DEN110006 is an FDA 510(k) submission for the VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR. This device is classified as a Biological Sterilization Process Indicator With Recombinant-dna Plasmid (Class II - Special Controls, product code OWP).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Not Cleared (DENG) decision on July 12, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2805. 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..
| 510(k) Number | DEN110006 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 06, 2011 |
| Decision Date | July 12, 2013 |
| Days to Decision | 675 days |
| Submission Type | Post-NSE |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | OWP — Biological Sterilization Process Indicator With Recombinant-dna Plasmid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2805 |
| Definition | 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. |