The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Vitamin D Total Assay.
| Device ID | K110586 |
| 510k Number | K110586 |
| Device Name: | ADVIA CENTAUR VITAMIN D TOTAL ASSAY |
| Classification | System, Test, Vitamin D |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Contact | Neil Parker |
| Correspondent | Neil Parker Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Product Code | MRG |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2011-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600345 | K110586 | 000 |
| 00630414588773 | K110586 | 000 |
| 00630414587882 | K110586 | 000 |
| 00630414586212 | K110586 | 000 |
| 00630414585093 | K110586 | 000 |