510(k) K232103
K232103 is an FDA 510(k) premarket notification submitted by Terragene S.A. for the device "Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)". The FDA issued a decision of Substantially Equivalent on April 5, 2024. The device falls under product code QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator), a Class II device regulated under 21 CFR 880.2800. Terragene S.A. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2024
- Date Received
- July 14, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.