The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Vitamin B12 Master Curve Material, Total Hcg Master Curve Material, And Testosterone Master Curve Material.
| Device ID | K140505 |
| 510k Number | K140505 |
| Device Name: | ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Contact | Fatima Pacheco |
| Correspondent | Fatima Pacheco Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-03-31 |
| Summary: | summary |