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) Assay;advia Centaur Vitd Total Calibrators,quality Control & Master Control Materia.
| Device ID | K133156 |
| 510k Number | K133156 |
| Device Name: | ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA |
| Classification | System, Test, Vitamin D |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| 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 | 2013-10-17 |
| Decision Date | 2014-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414602721 | K133156 | 000 |
| 00630414592497 | K133156 | 000 |
| 00630414600376 | K133156 | 000 |
| 00630414293837 | K133156 | 000 |
| 00630414234472 | K133156 | 000 |
| 00630414234489 | K133156 | 000 |
| 00630414592503 | K133156 | 000 |
| 00630414592718 | K133156 | 000 |
| 00630414600369 | K133156 | 000 |
| 00630414301334 | K133156 | 000 |