DEN110002 is an FDA 510(k) submission for the SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT. This device is classified as a Liquid Chemical Processing System (Class II - Special Controls, product code OVY).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Not Cleared (DENG) decision on March 30, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6887. The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring..
| 510(k) Number | DEN110002 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 01, 2011 |
| Decision Date | March 30, 2012 |
| Days to Decision | 242 days |
| Submission Type | Post-NSE |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | OVY — Liquid Chemical Processing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6887 |
| Definition | The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring. |