FDA Product Code
FDA Product Code OWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2805
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2018-06-13 | Special | PDF ↗ |
| K162945 | VERIFY ASSERT STEAM Process Challenge Device | STERIS Corporation | 2017-04-28 | Traditional | PDF ↗ |
| K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | STERIS Corporation | 2017-03-24 | Traditional | PDF ↗ |
| K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2017-03-24 | Traditional | PDF ↗ |
| DEN110006 | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR | STERIS Corporation | 2013-07-12 | Post-NSE | — |
Product code OWP · Class II · General Hospital. Data: openFDA.