K191999 is an FDA 510(k) clearance for the Sterilucent VH2O2 Chemical Indicators. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Sterilucent, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 21, 2019, 87 days after receiving the submission on July 26, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K191999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2019 |
| Decision Date | October 21, 2019 |
| Days to Decision | 87 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 |