K141580 is an FDA 510(k) clearance for the STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Tso3, Inc. (Vancouver, US). The FDA issued a Cleared decision on December 17, 2014, 187 days after receiving the submission on June 13, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K141580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2014 |
| Decision Date | December 17, 2014 |
| Days to Decision | 187 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 |