K242538 is an FDA 510(k) clearance for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493. 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 November 25, 2024, 91 days after receiving the submission on August 26, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K242538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2024 |
| Decision Date | November 25, 2024 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| 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 |