K191236 is an FDA 510(k) clearance for the 3M™ Attest™ Steam Chemical Integrators. 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 22, 2019, 198 days after receiving the submission on May 8, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K191236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 198 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 |