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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