The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Acs 180 And Advia Centaur Ft4 Immunoassays.
| Device ID | K080167 |
| 510k Number | K080167 |
| Device Name: | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-23 |
| Decision Date | 2008-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414553429 | K080167 | 000 |
| 00630414535432 | K080167 | 000 |
| 00630414535418 | K080167 | 000 |
| 00630414599144 | K080167 | 000 |