FDA.reportPublic FDA data

510(k) K244042

Device
Calcium2
Applicant
Abbott Ireland
510(k) number
K244042
Product code
CJY
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-10
Date received
2024-12-30
Regulation
862.1145
Classification name
Azo Dye, Calcium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Cherie Lipowsky
Address
Diagnostic Divison Lisnamuck IE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CJY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SAS2019-07-26
K182042Randox Calcium (Ca)Randox Laboratories, Ltd.2018-10-23
K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup2015-07-22
K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SAS2013-07-03
K120626EON CALCIUM REGENTVital Diagnostics (Manufacturing) Ptyltd2012-08-22
K083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)Siemens Healthcare Diagnostics2009-04-02
K072356S-TEST CAAlfa Wassermann Diagnostic Technologies, Inc.2008-06-24
K073355CALCIUM, SCAL, NORTROL, ABTROLThermofisher Scientific OY2008-02-28
K072443VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAYOrtho-Clinical Diagnostics, Inc.2007-09-24
K072440VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)Ortho-Clinical Diagnostics, Inc.2007-09-20
K062855CALCIUMAbbott Laboratories2006-11-22
K061575OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117Olympus America, Inc.2006-10-05
K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91Diagnostic Chemicals , Ltd.2005-11-10
K040972CALCIUM, AZO DYE REAGENTGenchem, Inc.2004-12-27
K021334WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5Wiener Laboratories Saic2002-09-10