Elan Holdings, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K013152ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITSNovember 9, 2001
K012474ATAC PAK CPK REAGENT KITOctober 3, 2001
K010488ATAC PAK AST REAGENT KITApril 9, 2001
K000958ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITSMay 24, 2000
K000900ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITSMay 2, 2000
K992842HICHEM ISE ELECTROLYTE REFERENCENovember 26, 1999
K992844HICHEM ISE ELECTROLYTE BUFFERNovember 26, 1999
K992845HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KITOctober 18, 1999
K992846HICHEM TOTAL PROTEIN REAGENTOctober 18, 1999
K992847HICHEM BUN REAGENTOctober 14, 1999
K991789ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSJuly 9, 1999
K991387ELAN ALKALINE PHOSPHATE REAGENT KITMay 19, 1999