The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Cyfra 21-1 Calcheck 5.
| Device ID | K162173 |
| 510k Number | K162173 |
| Device Name: | Elecsys CYFRA 21-1 CalCheck 5 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-03 |
| Decision Date | 2017-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630942541 | K162173 | 000 |