510(k) Report

Devices descending from K970389

8 later devices reach Thyroid Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053531Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 CalibratorDade Behring, Inc.20067—
+2K140859Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…Siemens Healthcare Diagnostics, Inc.201403
+2K073604Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…Dade Behring, Inc.200857
+3K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…Siemens Healthcare Diagnostics20250—
+3K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc.201316
+3K100778Dimension Exl Loci Thyroid Calibrator, Model RC 610ASiemens Healthcare Diagnostics20100—
+3K081103Loci Thyroid Calibrator with Model RC610Siemens Healthcare Diagnostics, Inc.20080—
+4K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…Siemens Healthcare Diagnostics, Inc.201402