The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Tsh.
| Device ID | K141999 |
| 510k Number | K141999 |
| Device Name: | ADVIA CENTAUR TSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Alex Hsu |
| Correspondent | Alex Hsu Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2015-04-22 |
| Summary: | summary |