VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
FDA 510(k) clearance K233682 · decided 2023-12-15
Clearance details
- K-number
- K233682
- Device name
- VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-11-16
- Decision date
- 2023-12-15
- Days to decision
- 29 days
- Clearance type
- Special
- 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 (K231746) | STERIS Corporation | 2023-09-11 |
| VERIFY Spore Test Strip for S40 Sterilant (K180553) | STERIS Corporation | 2018-05-29 |
| SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT (DEN110002) | STERIS Corporation | 2012-03-30 |
Recalls involving this device
No recalls on record reference this clearance.