K240717 is an FDA 510(k) clearance for the 3M? Attest? Rapid Readout Biological Indicator 1295 and 3M? Attest? Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on June 27, 2024, 104 days after receiving the submission on March 15, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K240717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2024 |
| Decision Date | June 27, 2024 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |