K183300 is an FDA 510(k) clearance for the VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Steris Corporations (Mentor, US). The FDA issued a Cleared decision on January 3, 2019, 37 days after receiving the submission on November 27, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K183300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2018 |
| Decision Date | January 03, 2019 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |