The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000 Third Generation Tsh, Immulite 2000 Free T4.
| Device ID | K160647 |
| 510k Number | K160647 |
| Device Name: | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 -5097 |
| Contact | Matthew Gee |
| Correspondent | Matthew Gee Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 -5097 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-05-31 |
| Summary: | summary |