The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Tsh3-ultra Method.
| Device ID | K083844 |
| 510k Number | K083844 |
| Device Name: | ADVIA CENTAUR TSH3-ULTRA METHOD |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Ernest Joseph |
| Correspondent | Ernest Joseph SIEMENS HEALTHCARE DIAGNOSTICS 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 | 2008-12-24 |
| Decision Date | 2009-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414565668 | K083844 | 000 |
| 00630414563268 | K083844 | 000 |
| 00630414551531 | K083844 | 000 |
| 00630414535654 | K083844 | 000 |
| 00630414535647 | K083844 | 000 |