K200272 is an FDA 510(k) clearance for the Terragene Chemdye. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on June 30, 2020, 147 days after receiving the submission on February 4, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K200272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2020 |
| Decision Date | June 30, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JOJ - Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |