ClearanceBrief
Panels › Clinical Chemistry › Product code CJY · Class 2

Azo Dye, Calcium

Regulation 862.1145

0510(k)s in 12 months (47 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in CJY

Decided510(k)Device and applicantCode
Feb 10, 2025K244042Calcium2
Abbott Ireland, IE
CJY
Jul 26, 2019K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
HORIBA ABX SAS, FR
CJY
Oct 23, 2018K182042Randox Calcium (Ca)
Randox Laboratories, Ltd., GB
CJY
Jul 22, 2015K151113ELITech Clinical Systems CALCIUM ARSENAZO
Elitechgroup, FR
CJY
Jul 3, 2013K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
HORIBA ABX SAS, FR
CJY
Aug 22, 2012K120626EON CALCIUM REGENT
Vital Diagnostics (Manufacturing) Ptyltd, AU
CJY
Apr 2, 2009K083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
Siemens Healthcare Diagnostics
CJY
Jun 24, 2008K072356S-TEST CA
Alfa Wassermann Diagnostic Technologies, Inc.
CJY
Feb 28, 2008K073355CALCIUM, SCAL, NORTROL, ABTROL
Thermofisher Scientific OY, FI
CJY
Sep 24, 2007K072443VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
Ortho-Clinical Diagnostics, Inc.
CJY
Sep 20, 2007K072440VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
Ortho-Clinical Diagnostics, Inc.
CJY
Nov 22, 2006K062855CALCIUM
Abbott Laboratories
CJY
Oct 5, 2006K061575OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
Olympus America, Inc.
CJY
Nov 10, 2005K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
Diagnostic Chemicals , Ltd., CA
CJY
Dec 27, 2004K040972CALCIUM, AZO DYE REAGENT
Genchem, Inc.
CJY
Sep 10, 2002K021334WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
Wiener Laboratories Saic, AR
CJY
Jul 19, 2002K022049MODIFICATION TO RAICHEM CALCIUM REAGENT
Hemagen Diagnostics, Inc.
CJY
Jul 9, 2001K011441JAS CALCIUM (ARSENAZO) REAGENT
Jas Diagnostics, Inc.
CJY
Dec 17, 1998K983789CARESIDE CALCIUM, ORIGINAL
Careside, Inc.
CJY
Jul 29, 1998K981794HICHEM CALCIUM REAGENT KIT
Hichem Diagnostics
CJY
Jun 24, 1998K982035OLYMPUS CALCIUM ARSENAZO III REAGENT
Olympus Diagnostica GmbH
CJY
Jun 16, 1998K981578CA
Abbott Laboratories
CJY
May 18, 1998K981232CA
Abbott Mfg., Inc.
CJY
Feb 2, 1998K974607RANDOX CALCIUM
Randox Laboratories, Ltd., IE
CJY
Oct 10, 1996K963536SIGMA DIAGNOSTICS CALICIUM REAGENT
Sigma Diagnostics, Inc.
CJY
May 7, 1996K961226EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
Johnson & Johnson Clinical Diagnostics, Inc.
CJY
Aug 31, 1995K953395SYNERMED CALCIUM REAGENT KIT
Synermed, Inc., CA
CJY
Dec 6, 1994K944255DMA CALCIUM PLUS PROCEDURE
Data Medical Associates, Inc.
CJY
May 13, 1994K941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
Hi Chem, Inc.
CJY
Mar 11, 1994K933678SIGMA CALCIUM REAGENT
Sigma Chemical Co.
CJY
Aug 4, 1992K922835CALCIUM (AZ III) REAGENT
King Diagnostics, Inc.
CJY
Jul 17, 1990K902476CALCIUM:ARSENAZO III
Amresco, Inc.
CJY
Apr 3, 1990K900231COULTER CALCIUM REAGENT
Coulter Corp.
CJY
Dec 12, 1989K895873CALCIUM, CATALOGUE NUMBER140-20
Diagnostic Chemicals, Ltd. (Usa)
CJY
Oct 12, 1989K894476CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
Catachem, Inc.
CJY
Oct 4, 1989K894204CALCIUM (ARSENAZO III) REAGENT
Sigma Diagnostics, Inc.
CJY
Aug 10, 1989K891061BIOTROL CALCIUM MONOREACTIF
Biotrol, USA, Inc.
CJY
Apr 10, 1989K890584HI CHEM CALCIUM REAGENT #88808
Hichem Diagnostics
CJY
Feb 27, 1989K890302CALCIUM PLUS PROCEDURE
Data Medical Associates, Inc.
CJY
Oct 25, 1988K883453ROCHE REAGENT FOR CALCIUM
Roche Diagnostic Systems, Inc.
CJY
Jun 10, 1988K880576RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
Reagents Applications, Inc.
CJY
Apr 5, 1988K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
Advanced Biomedical Methods, Inc.
CJY
Mar 15, 1988K880242KONE CALCIUM TEST
The Rupp & Bowman Co.
CJY
Nov 10, 1981K813040ULTRACHEM CA, ITEM #64975
Harleco
CJY
Nov 14, 1977K771928CALCIUM SET, ITEM NO. 65004
Harleco
CJY
Jul 11, 1977K770817ULTRACHEM CALCIUM
Harleco
CJY
Nov 30, 1976K761029AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL
Harleco
CJY

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