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Elan Diagnostics

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K030003 ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORCIG2003-09-29 View
510(k) K030014 ATAC TOTAL BILIRUBIN REAGENTCIG2003-09-26 View
510(k) K030621 ATAC CALIBRATORJIX2003-03-19 View
510(k) K023105 ATAC CALCIUM REAGENT AND ATAC CALIBRATORCIC2003-03-13 View
510(k) K030010 ATAC PAK MAGNESIUM REAGENTJGJ2003-03-10 View
510(k) K030006 ATAC PAK ALBUMIN REAGENTCIX2003-03-07 View
510(k) K030015 ATAC PAK PHOSPHORUS REAGENTCEO2003-03-07 View
510(k) K023407 ATAC PAK CREATININE REAGENT AND ATAC CALIBRATORCGX2003-02-14 View
510(k) K021385 ATAC PAK BUN REAGENTCDQ2002-07-12 View
510(k) K020575 ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITSMRR2002-04-12 View
510(k) K002285 ATAC PAK ALP REAGENT KITCJE2000-09-26 View
510(k) K000556 ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITSCFR2000-05-17 View
510(k) K992029 ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSLBR1999-08-12 View
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