Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
FDA 510(k) clearance K232103 · decided 2024-04-05
Clearance details
- K-number
- K232103
- Device name
- Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- Applicant
- Terragene S.A.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-14
- Decision date
- 2024-04-05
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- QKM
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Alvear, AR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K212022) | 3M Company | 2022-04-20 |
| CELERITY HP Chemical Indicator (K213262) | STERIS Corporation | 2022-01-07 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (K203284) | 3M Company | 2020-12-07 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K193110) | 3M Healthcare | 2020-03-13 |
Recalls involving this device
No recalls on record reference this clearance.