The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Vitamin D Total (vitd).
| Device ID | K200509 |
| 510k Number | K200509 |
| Device Name: | ADVIA Centaur Vitamin D Total (VitD) |
| Classification | System, Test, Vitamin D |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10259 1 |
| Contact | Paul Dasilva |
| Correspondent | Paul Dasilva Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10259 1 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-05-29 |