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DFC — Lipoprotein, Low-Density, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DFC
Device Class
Class II
Regulation Number
866.5600
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241220roche diagnostics operationsTina-quant Lipoprotein(a) Gen.2 MolarityJanuary 24, 2025
K211058sentinel chLp(a) UltraDecember 22, 2022
K180074diazyme laboratoriesDiazyme Lipoprotein (a) AssayMarch 22, 2018
K123046siemens healthcare diagnosticsADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORDecember 20, 2012
K122722roche diagnosticsCOBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (ANovember 29, 2012
K082488general atomicsDIAZYME LP(A) ASSAYJanuary 13, 2009
K063838thermo electronLIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHSeptember 27, 2007
K050487biokitQUANTIA LA(A)April 26, 2005
K023853kamiya biomedicalK-ASSAY LP(A) CONTROLSDecember 13, 2002
K021660kamiya biomedicalK-ASSAY LP(A) ASSAYJuly 25, 2002
K013359denka seikenLP(A)-LATEX SEIKEN ASSAY KITMarch 8, 2002
K013128dade behringN LATEX LP(A)January 18, 2002
K013206roche diagnosticsTINA-QUANT APOLIPOPROTEIN B VER.2November 16, 2001
K013207roche diagnosticsTINA-QUANT APOLIPOPROTEIN B VER.2November 13, 2001
K001933wako chemicals usaWAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIOJuly 24, 2000
K001931wako chemicals usaWAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSETJuly 24, 2000
K001934wako chemicals usaWAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CXJuly 24, 2000
K001929wako chemicals usaWAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARAJuly 24, 2000
K001919wako chemicals usaWAKO AUTOKIT LP(A)/DADE DEMENSIONJuly 23, 2000
K001921wako chemicals usaWAKO AUTOKIT LP(A)/EXPRESS 550July 23, 2000