The following data is part of a premarket notification filed by Biovica International Ab with the FDA for Divitum Tka.
| Device ID | K202852 |
| 510k Number | K202852 |
| Device Name: | DiviTum TKa |
| Classification | Cytokeratin Fragments 21-1 Eia Kit |
| Applicant | Biovica International AB Dag Hammarskjölds Väg 54B Uppsala, SE 75237 |
| Contact | Wing Cheng |
| Correspondent | Joakim Arwidson Biovica International AB Dag Hammarskjölds Väg 54B Uppsala, SE 75237 |
| Product Code | OVK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2022-07-29 |