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KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Class II

FDA Device Classification

Classification Details

Product Code
KLI
Device Class
Class II
Regulation Number
862.1700
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160495ortho-clinical diagnosticsVITROS® Automation SolutionsOctober 18, 2016
K131515alfa wassermannACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAugust 14, 2013
K103484wallac oy, a subsidiary of perkinelmerGSP NEONATAL THYROXINE (T4)April 22, 2011
K082638siemens healthcare diagnosticsADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLFebruary 26, 2009
K030860monobindACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300August 22, 2003
K023369beckman coulterACCESS TOTAL T4 ASSAYDecember 9, 2002
K001603repromedixREPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)October 5, 2000
K000600syva co., dade behringSYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORSMarch 27, 2000
K991432biocheckBIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007June 2, 1999
K982298biotecx laboratoriesOPTICOAT T4 EIA KITFebruary 3, 1999
K983440abbott laboratoriesABBOTT ARCHITECT TOTAL T4November 25, 1998
K981377schiapparelli biosystemsACE T4 REAGENT T4 CALIBRATORSJune 10, 1998
K972974neometricsACCUWELL T4-EIAOctober 6, 1997
K971709monobindTOTAL THROXINE MICROPLATE EIA(225-300)June 16, 1997
K971269diagnostic systems laboratoriesDSL ACTIVE T4 EIAMay 22, 1997
K971203beckman instrumentsSYNCHRON SYSTEMS THYROXINE REAGENTMay 16, 1997
K964721johnson and johnson clinical diagnosticsVITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIDecember 18, 1996
K951014isolabISOLAB'S T4 TEST KITOctober 18, 1996
K962211united biotechUBI MAGIWEL THYROXINE (T4) QUANTITATIVEJuly 8, 1996
K953837biocircuitsBIOCIRCUITS IOS T4 TEST CARTRIDGENovember 20, 1995