The following data is part of a premarket notification filed by Terragene Sa with the FDA for Terragene Bionova(r) Scbi (bt220, Bt221, Bt222, Bt223), Terragene Bionova (r) Pcd (pcd220-c, Pcd220-2, Pcd222-c, Pcd222-2), And Terragene Bionova(r) Ic10/20fr Reader Incubator.
| Device ID | K163646 |
| 510k Number | K163646 |
| Device Name: | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), And Terragene Bionova(R) IC10/20FR Reader Incubator |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Terragene SA Guemes 2879 Rosario, AR 2000 |
| Contact | Maria Victoria Quiroga |
| Correspondent | Raymond Kelly Licensale Inc 68 Southwoods Ter 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 | 2016-12-23 |
| Decision Date | 2017-11-02 |