FDA 510(k) Applications for Medical Device Product Code "KLI"
(Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)

FDA 510(k) Number Applicant Device Name Decision Date
K983440 ABBOTT LABORATORIES ABBOTT ARCHITECT TOTAL T4 11/25/1998
K131515 ALFA WASSERMANN ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT 08/14/2013
K023369 BECKMAN COULTER, INC. ACCESS TOTAL T4 ASSAY 12/09/2002
K971203 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS THYROXINE REAGENT 05/16/1997
K991432 BIOCHECK, INC. BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 06/02/1999
K982298 BIOTECX LABORATORIES, INC. OPTICOAT T4 EIA KIT 02/03/1999
K971269 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE T4 EIA 05/22/1997
K951014 ISOLAB, INC. ISOLAB'S T4 TEST KIT 10/18/1996
K964721 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) 12/18/1996
K030860 MONOBIND ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 08/22/2003
K971709 MONOBIND TOTAL THROXINE MICROPLATE EIA(225-300) 06/16/1997
K972974 NEOMETRICS, INC. ACCUWELL T4-EIA 10/06/1997
K160495 Ortho-Clinical Diagnostics, Inc. VITROS« Automation Solutions 10/18/2016
K001603 REPROMEDIX CORP. REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) 10/05/2000
K981377 SCHIAPPARELLI BIOSYSTEMS, INC. ACE T4 REAGENT T4 CALIBRATORS 06/10/1998
K082638 Siemens Healthcare Diagnostics Inc. ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL 02/26/2009
K000600 SYVA CO., DADE BEHRING, INC. SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS 03/27/2000
K962211 UNITED BIOTECH, INC. UBI MAGIWEL THYROXINE (T4) QUANTITATIVE 07/08/1996
K103484 WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. GSP NEONATAL THYROXINE (T4) 04/22/2011


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