The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Calset Igf-1.
| Device ID | K170938 |
| 510k Number | K170938 |
| Device Name: | CalSet IGF-1 |
| Classification | Calibrator, Secondary |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Lisa K. Klinedinst |
| Correspondent | Lisa K. Klinedinst Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-30 |
| Decision Date | 2017-04-26 |
| Summary: | summary |