K192937 is an FDA 510(k) clearance for the 3M Comply Hydrogen Peroxide Chemical Indicator. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on November 16, 2019, 29 days after receiving the submission on October 18, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K192937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2019 |
| Decision Date | November 16, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |