ClearanceBrief
510(k) K140842 ยท CEC Radioimmunoassay, Free Thyroxine

DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART

ApplicantSiemens Healthcare Diagnostics, Inc., Newark DE, US
DecisionSubstantially Equivalent, Nov 26, 2014
ReceivedApr 2, 2014
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K140842

DateFirm and productCodeLinked 510(k)
May 4, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge
Terminated		 JLWNone listed
May 4, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Free Thyroxine (FT4L) Flex reagent cartridge
Terminated		 CECNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.