VERIFY Assert Self-Contained Biological Indicator
FDA 510(k) clearance K181442 · decided 2018-06-13
Clearance details
- K-number
- K181442
- Device name
- VERIFY Assert Self-Contained Biological Indicator
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-06-01
- Decision date
- 2018-06-13
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- OWP
- Device class
- 2
- Regulation number
- 880.2805
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VERIFY ASSERT STEAM Process Challenge Device (K162945) | STERIS Corporation | 2017-04-28 |
| VERIFY Assert Self-Contained Biological Indicator (K162701) | STERIS Corporation | 2017-03-24 |
| VERIFY Incubator for Assert Self Contained Biological Indicators (K163587) | STERIS Corporation | 2017-03-24 |
| VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR (DEN110006) | STERIS Corporation | 2013-07-12 |
Recalls involving this device
No recalls on record reference this clearance.