K203560 is an FDA 510(k) clearance for the STERIZONE VP4 Test Pack. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Tso3 Inc., Now A Part of Stryker (Québec, CA). The FDA issued a Cleared decision on March 24, 2021, 107 days after receiving the submission on December 7, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K203560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2020 |
| Decision Date | March 24, 2021 |
| Days to Decision | 107 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 |