510(k) Report

Devices descending from K073604

5 later devices reach Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…Siemens Healthcare Diagnostics20250—
+1K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc.201316
+1K100778Dimension Exl Loci Thyroid Calibrator, Model RC 610ASiemens Healthcare Diagnostics20100—
+1K081103Loci Thyroid Calibrator with Model RC610Siemens Healthcare Diagnostics, Inc.20080—
+2K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…Siemens Healthcare Diagnostics, Inc.201402