FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K981578 |
ABBOTT LABORATORIES |
CA |
06/16/1998 |
K062855 |
ABBOTT LABORATORIES |
CALCIUM |
11/22/2006 |
K981232 |
ABBOTT MFG., INC. |
CA |
05/18/1998 |
K072356 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
S-TEST CA |
06/24/2008 |
K983789 |
CARESIDE, INC. |
CARESIDE CALCIUM, ORIGINAL |
12/17/1998 |
K051757 |
DIAGNOSTIC CHEMICALS LTD. |
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 |
11/10/2005 |
K151113 |
ELITechGroup |
ELITech Clinical Systems CALCIUM ARSENAZO |
07/22/2015 |
K040972 |
GENCHEM, INC. |
CALCIUM, AZO DYE REAGENT |
12/27/2004 |
K022049 |
HEMAGEN DIAGNOSTICS, INC. |
MODIFICATION TO RAICHEM CALCIUM REAGENT |
07/19/2002 |
K981794 |
HICHEM DIAGNOSTICS |
HICHEM CALCIUM REAGENT KIT |
07/29/1998 |
K123171 |
HORIBA ABX S.A.S. |
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT |
07/03/2013 |
K191396 |
Horiba ABX SAS |
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe |
07/26/2019 |
K011441 |
JAS Diagnostics, Inc. |
JAS CALCIUM (ARSENAZO) REAGENT |
07/09/2001 |
K961226 |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE |
05/07/1996 |
K061575 |
OLYMPUS AMERICA, INC. |
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 |
10/05/2006 |
K982035 |
OLYMPUS DIAGNOSTICA GMBH |
OLYMPUS CALCIUM ARSENAZO III REAGENT |
06/24/1998 |
K072443 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY |
09/24/2007 |
K072440 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) |
09/20/2007 |
K182042 |
Randox Laboratories Ltd. |
Randox Calcium (Ca) |
10/23/2018 |
K974607 |
RANDOX LABORATORIES, LTD. |
RANDOX CALCIUM |
02/02/1998 |
K083386 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) |
04/02/2009 |
K963536 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS CALICIUM REAGENT |
10/10/1996 |
K073355 |
THERMO FISHER SCIENTIFIC OY |
CALCIUM, SCAL, NORTROL, ABTROL |
02/28/2008 |
K120626 |
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
EON CALCIUM REGENT |
08/22/2012 |
K021334 |
WIENER LABORATORIES S.A.I.C. |
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 |
09/10/2002 |