The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Vitamin D Total Ii, Vitamin D Total Ii Calset, Precicontrol Vitamin D Total Ii, Vitamin D Calcheck 5.
| Device ID | K162840 |
| 510k Number | K162840 |
| Device Name: | Elecsys Vitamin D Total II, Vitamin D Total II CalSet, PreciControl Vitamin D Total II, Vitamin D CalCheck 5 |
| Classification | System, Test, Vitamin D |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Linda Mccammack |
| Correspondent | Linda Mccammack Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | MRG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-11 |
| Decision Date | 2017-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336129203 | K162840 | 000 |
| 07613336129197 | K162840 | 000 |