The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000 Free T4.
| Device ID | K083373 |
| 510k Number | K083373 |
| Device Name: | IMMULITE 2000 FREE T4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Contact | Philip Liu |
| Correspondent | Philip Liu Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-14 |
| Decision Date | 2009-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414996868 | K083373 | 000 |
| 00630414996851 | K083373 | 000 |
| 00630414996844 | K083373 | 000 |