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510(k) K880576

Device
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
Applicant
REAGENTS APPLICATIONS, INC.
510(k) number
K880576
Product code
CJY  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-10
Date received
1988-02-10
Regulation
862.1145
Classification name
Azo Dye, Calcium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALFRED E PEACOCK,JR
Address
8225 Mercury Ct. San Diego CA US 92111 92111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CJY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K244042Calcium2Abbott Ireland2025-02-10
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

Legacy Summary#

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FDA Review#

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