Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Elan Holdings, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K013152 ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITSLBS2001-11-09 View
510(k) K012474 ATAC PAK CPK REAGENT KITCGS2001-10-03 View
510(k) K010488 ATAC PAK AST REAGENT KITCIT2001-04-09 View
510(k) K000958 ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITSCDQ2000-05-24 View
510(k) K000900 ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITSCHH2000-05-02 View
510(k) K992842 HICHEM ISE ELECTROLYTE REFERENCEJGS1999-11-26 View
510(k) K992844 HICHEM ISE ELECTROLYTE BUFFERJGS1999-11-26 View
510(k) K992846 HICHEM TOTAL PROTEIN REAGENTCEK1999-10-18 View
510(k) K992845 HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KITJIX1999-10-18 View
510(k) K992847 HICHEM BUN REAGENTLFP1999-10-14 View
510(k) K991789 ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSLBR1999-07-09 View
510(k) K991387 ELAN ALKALINE PHOSPHATE REAGENT KITCJE1999-05-19 View
↑