The following data is part of a premarket notification filed by Terragene Sa with the FDA for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye.
| Device ID | K191021 |
| 510k Number | K191021 |
| Device Name: | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Terragene SA Ruta Nacional No. 9, Km 280, Parque Industrial Micropi Alvear, AR 2130 |
| Contact | Maria Victoria Rocha |
| Correspondent | Raymond Kelly Licensale Inc 68 Southwoods Terrace Southbury, CT 06488 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-17 |
| Decision Date | 2019-09-13 |