The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Vitamin D Total Iii.
| Device ID | K210901 |
| 510k Number | K210901 |
| Device Name: | Elecsys Vitamin D Total III |
| Classification | System, Test, Vitamin D |
| Applicant | Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 |
| Contact | Jamie Ferguson |
| Correspondent | Jamie Ferguson Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-26 |
| Decision Date | 2021-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336184615 | K210901 | 000 |
| 07613336172650 | K210901 | 000 |