The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Tsh3-ultra.
| Device ID | K150403 |
| 510k Number | K150403 |
| Device Name: | ADVIA Centaur TSH3-Ultra |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Contact | Matthew Gee |
| Correspondent | Matthew Gee SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600185 | K150403 | 000 |
| 00630414600178 | K150403 | 000 |
| 00630414600161 | K150403 | 000 |
| 00630414293806 | K150403 | 000 |
| 00630414293875 | K150403 | 000 |