OWP · Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
General Hospital · 21 CFR 880.2805 · Class 2
Overview
| Product Code | OWP |
|---|---|
| Device Name | Biological Sterilization Process Indicator With Recombinant-Dna Plasmid |
| Regulation | 21 CFR 880.2805 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | Jun 13, 2018 | SESE |
| K162945 | VERIFY ASSERT STEAM Process Challenge Device | STERIS Corporation | Apr 28, 2017 | SESE |
| K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | STERIS Corporation | Mar 24, 2017 | SESE |
| K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | Mar 24, 2017 | SESE |
| DEN110006 | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR | STERIS Corporation | Jul 12, 2013 | DENG |
Top Applicants
- STERIS Corporation — 5 clearances
