K232103 is an FDA 510(k) clearance for the Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40). This device is classified as a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II - Special Controls, product code QKM).
Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on April 5, 2024, 266 days after receiving the submission on July 14, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800. A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process..
| 510(k) Number | K232103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2023 |
| Decision Date | April 05, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | QKM - A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
| Definition | A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process. |