K191021 is an FDA 510(k) clearance for the Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye. This device is classified as a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC).
Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on September 13, 2019, 149 days after receiving the submission on April 17, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K191021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2019 |
| Decision Date | September 13, 2019 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |