The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur System With Streamlab Analytical Workcell.
| Device ID | K082638 |
| 510k Number | K082638 |
| Device Name: | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-10 |
| Decision Date | 2009-02-26 |
| Summary: | summary |