K180553 is an FDA 510(k) clearance for the VERIFY Spore Test Strip for S40 Sterilant. This device is classified as a Liquid Chemical Processing System (Class II - Special Controls, product code OVY).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 29, 2018, 89 days after receiving the submission on March 1, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6887. The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring..
| 510(k) Number | K180553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2018 |
| Decision Date | May 29, 2018 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | OVY — Liquid Chemical Processing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6887 |
| Definition | The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring. |