The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Cyfra 21-1, Elecsys Cyfra 21-1 Calset, Precicontrol Tumor Marker.
| Device ID | K160915 |
| 510k Number | K160915 |
| Device Name: | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker |
| Classification | Cytokeratin Fragments 21-1 Eia Kit |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Adam Clark |
| Correspondent | Adam Clark ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | OVK |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630940004 | K160915 | 000 |
| 04015630934805 | K160915 | 000 |
| 04015630909834 | K160915 | 000 |