VERIFY Spore Test Strip for S40 Sterilant
FDA 510(k) clearance K180553 · decided 2018-05-29
Clearance details
- K-number
- K180553
- Device name
- VERIFY Spore Test Strip for S40 Sterilant
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-03-01
- Decision date
- 2018-05-29
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- OVY
- Device class
- 2
- Regulation number
- 880.6887
- 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 SPORE TEST STRIP for S40 STERILANT CONCENTRATE (K233682) | STERIS Corporation | 2023-12-15 |
| VERIFY Spore Test Strip for S40 Sterilant Concentrate (K231746) | STERIS Corporation | 2023-09-11 |
| SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT (DEN110002) | STERIS Corporation | 2012-03-30 |
Recalls involving this device
No recalls on record reference this clearance.