Elan Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORSeptember 29, 2003
K030014ATAC TOTAL BILIRUBIN REAGENTSeptember 26, 2003
K030621ATAC CALIBRATORMarch 19, 2003
K023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORMarch 13, 2003
K030010ATAC PAK MAGNESIUM REAGENTMarch 10, 2003
K030015ATAC PAK PHOSPHORUS REAGENTMarch 7, 2003
K030006ATAC PAK ALBUMIN REAGENTMarch 7, 2003
K023407ATAC PAK CREATININE REAGENT AND ATAC CALIBRATORFebruary 14, 2003
K021385ATAC PAK BUN REAGENTJuly 12, 2002
K020575ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITSApril 12, 2002
K002285ATAC PAK ALP REAGENT KITSeptember 26, 2000
K000556ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITSMay 17, 2000
K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSAugust 12, 1999