The following data is part of a premarket notification filed by Plasmapp Co., Ltd. with the FDA for Terragene Bionova Scbi (bt96), Terragene Bionova Reader Incubators (ic10/20frlcd, Mini-bio), Terragene Chemdye (cd42), Terragene Cintape (ct40).
| Device ID | K212193 |
| 510k Number | K212193 |
| Device Name: | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Plasmapp Co., Ltd. BVC-111, 125, Gwahak-ro, Yuseong-gu Daejeon, KR 34141 |
| Contact | Seung Hun Lee |
| Correspondent | Candace Cederman CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, MD 21401 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-14 |
| Decision Date | 2021-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800066500207 | K212193 | 000 |
| 08800066500191 | K212193 | 000 |
| 08800066500184 | K212193 | 000 |
| 08800066500221 | K212193 | 000 |