K213296 is an FDA 510(k) clearance for the Anprolene SteriTest RRBI. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on April 12, 2022, 193 days after receiving the submission on October 1, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K213296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2021 |
| Decision Date | April 12, 2022 |
| Days to Decision | 193 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 |