K141698 is an FDA 510(k) clearance for the STERIZONE CHEMICAL INDICATOR. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Tso3, Inc. (Vancouver, US). The FDA issued a Cleared decision on December 17, 2014, 176 days after receiving the submission on June 24, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K141698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2014 |
| Decision Date | December 17, 2014 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |