K193110 is an FDA 510(k) clearance for the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E. This device is classified as a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II - Special Controls, product code QKM).
Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on March 13, 2020, 122 days after receiving the submission on November 12, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800. A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process..
| 510(k) Number | K193110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2019 |
| Decision Date | March 13, 2020 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QKM - A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
| Definition | A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process. |