K192673 is an FDA 510(k) clearance for the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228. 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 October 28, 2019, 32 days after receiving the submission on September 26, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K192673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2019 |
| Decision Date | October 28, 2019 |
| Days to Decision | 32 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 |