510(k) K232103
- Device
- Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- Applicant
- Terragene S.A.
- 510(k) number
- K232103
- Product code
- QKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-05
- Date received
- 2023-07-14
- Regulation
- 880.2800
- Classification name
- A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hernando Carrizo
- Address
- Ruta Nacional # 9, Km 280, Parque Industrial Micropi Alvear AR 2130 2130
FDA Registration Numbers#
- 8021896
- 3031841433
- 3042272797
- 3013145340
- 3004080920
- 3000251274
- 3015392401
- 3031757047
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QKM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2022-04-20 |
| K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022-01-07 |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020-12-07 |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020-03-13 |