The following data is part of a De Novo classification by Steris Corporation with the FDA for System 1e Process Biological Monitoring Kit.
| DeNovo ID | DEN110002 |
| Device Name: | SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT |
| Classification | Liquid Chemical Processing System |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert Sullivan |
| Product Code | OVY |
| CFR Regulation Number | 880.6887 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K100049 |
| Review Advisory Board | General Hospital |
| Classification Advisory | General Hospital |
| Type | Post-NSE |
| Date Received | 2011-08-01 |
| Decision Date | 2012-03-30 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995228453 | DEN110002 | 000 |