K200536 is an FDA 510(k) clearance for the 3MTM AttestTM Rapid 5 Steam-Plus Test Pack. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by 3M Complany (St. Paul, US). The FDA issued a Cleared decision on June 1, 2020, 90 days after receiving the submission on March 3, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K200536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2020 |
| Decision Date | June 01, 2020 |
| Days to Decision | 90 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 |