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 |