The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Loci Free Thyroxine Flex Reagent Cartridge, Ft4l, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart.
| Device ID | K140842 |
| 510k Number | K140842 |
| Device Name: | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Contact | Frances A Dillon |
| Correspondent | Frances A Dillon Siemens Healthcare Diagnostics Inc. PO BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-02 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768022098 | K140842 | 000 |