510(k) Report

Devices descending from K081074

2 later devices reach Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…Siemens Healthcare Diagnostics20250—
+1K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…Siemens Healthcare Diagnostics, Inc.201402