Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
FDA 510(k) K191021 · Terragene S.A.
510(k) numberK191021
Submission
- Device name
- Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
- Applicant
- Terragene S.A.
Alvear, AR - Received
- April 17, 2019
- Decision date
- September 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code FRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | 12/12/2024SE |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova®…FRC · Traditional | 09/18/2024SE |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye®…QKM · Traditional | 04/05/2024SE |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper…FRC · Traditional | 02/28/2023SE |
| K200272 | Terragene ChemdyeJOJ · Traditional | 06/30/2020SE |
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD…FRC · Traditional | 11/02/2017SE |
Questions and answers
When was Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye cleared by the FDA?
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye (K191021) received a 510(k) decision of Substantially Equivalent on September 13, 2019, 149 days after the submission was received.
What is the product code of K191021?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.