VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
FDA 510(k) clearance DEN110006 · decided 2013-07-12
Clearance details
- K-number
- DEN110006
- Device name
- VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
- Applicant
- STERIS Corporation
- Decision
- Unknown
- Date received
- 2011-09-06
- Decision date
- 2013-07-12
- Days to decision
- 675 days
- Clearance type
- Post-NSE
- 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
+ Add to Predicate Builder ◉ Watch STERIS Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VERIFY Assert Self-Contained Biological Indicator (K181442) | STERIS Corporation | 2018-06-13 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.