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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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