FDA 510(k) Applications Submitted by WYNN STOCKING

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
K960084 01/11/1996 HICHEM GLUCOSE/HK REAGENT KIT HI CHEM, INC.
K960115 01/11/1996 HICHEM BUN/UREA REAGENT KIT ELAN PHARMA, INC.
K000556 02/18/2000 ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS ELAN DIAGNOSTICS
K030528 02/19/2003 ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) CLINICAL DATA
K010488 02/20/2001 ATAC PAK AST REAGENT KIT ELAN HOLDINGS, INC.
K020575 02/21/2002 ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS ELAN DIAGNOSTICS
K040467 02/24/2004 VITALAB URIC ACID REAGENT CLINICAL DATA, INC.
K030621 02/27/2003 ATAC CALIBRATOR ELAN DIAGNOSTICS
K040508 02/27/2004 VITALAB MAGNESIUM REAGENT CLINICAL DATA, INC.
K040534 03/02/2004 VITALAB AMYLASE REAGENT CLINICAL DATA, INC.
K040631 03/10/2004 VITALAB DIRECT BILIRUBIN REAGENT CLINICAL DATA, INC.
K000900 03/21/2000 ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS ELAN HOLDINGS, INC.
K031042 04/01/2003 ATAC HEMOGLOBIN A1C REAGENT KIT CLINICAL DATA, INC.
K031044 04/01/2003 ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR CLINICAL DATA, INC.
K021385 05/02/2002 ATAC PAK BUN REAGENT ELAN DIAGNOSTICS
K981769 05/19/1998 HICHEM PHOSPHORUS REAGENT KIT ELAN PHARMA, INC.
K981794 05/21/1998 HICHEM CALCIUM REAGENT KIT HICHEM DIAGNOSTICS
K991789 05/25/1999 ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS ELAN HOLDINGS, INC.
K962247 06/11/1996 HICHEM CK/NAC REAGENT KIT ELAN PHARMA, INC.
K992029 06/16/1999 ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS ELAN DIAGNOSTICS
K071706 06/21/2007 ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) CLINICAL DATA, INC.
K982469 07/15/1998 HICHEM CHOLESTEROL REAGENT KIT ELAN PHARMA, INC.
K002285 07/26/2000 ATAC PAK ALP REAGENT KIT ELAN DIAGNOSTICS
K012474 08/02/2001 ATAC PAK CPK REAGENT KIT ELAN HOLDINGS, INC.
K992847 08/24/1999 HICHEM BUN REAGENT ELAN HOLDINGS, INC.
K992842 08/24/1999 HICHEM ISE ELECTROLYTE REFERENCE ELAN HOLDINGS, INC.
K992844 08/24/1999 HICHEM ISE ELECTROLYTE BUFFER ELAN HOLDINGS, INC.
K992845 08/24/1999 HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT ELAN HOLDINGS, INC.
K992846 08/24/1999 HICHEM TOTAL PROTEIN REAGENT ELAN HOLDINGS, INC.
K963383 08/27/1996 HICHEM ALP/AMP REAGENT KIT HICHEM DIAGNOSTICS
K023105 09/18/2002 ATAC CALCIUM REAGENT AND ATAC CALIBRATOR ELAN DIAGNOSTICS
K013152 09/20/2001 ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS ELAN HOLDINGS, INC.
K023407 10/10/2002 ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR ELAN DIAGNOSTICS
K033983 12/23/2003 VITALAB IRON REAGENT CLINICAL DATA, INC.
K034000 12/24/2003 VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR CLINICAL DATA, INC.


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