FDA 510(k) Applications Submitted by ELAN DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K030003 01/02/2003 ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR ELAN DIAGNOSTICS
K030006 01/02/2003 ATAC PAK ALBUMIN REAGENT ELAN DIAGNOSTICS
K030010 01/02/2003 ATAC PAK MAGNESIUM REAGENT ELAN DIAGNOSTICS
K030014 01/02/2003 ATAC TOTAL BILIRUBIN REAGENT ELAN DIAGNOSTICS
K030015 01/02/2003 ATAC PAK PHOSPHORUS REAGENT ELAN DIAGNOSTICS
K000556 02/18/2000 ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS ELAN DIAGNOSTICS
K020575 02/21/2002 ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS ELAN DIAGNOSTICS
K030621 02/27/2003 ATAC CALIBRATOR ELAN DIAGNOSTICS
K021385 05/02/2002 ATAC PAK BUN REAGENT ELAN DIAGNOSTICS
K992029 06/16/1999 ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS ELAN DIAGNOSTICS
K002285 07/26/2000 ATAC PAK ALP REAGENT KIT ELAN DIAGNOSTICS
K023105 09/18/2002 ATAC CALCIUM REAGENT AND ATAC CALIBRATOR ELAN DIAGNOSTICS
K023407 10/10/2002 ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR ELAN DIAGNOSTICS


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