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Azo Dye, Calcium

FDA product code CJY · 46 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1145
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-30 – 2025-02-10

CJY 2025-02-10

Calcium2

Applicant Abbott Ireland

K number K244042

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CJY 2019-07-26

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

Applicant HORIBA ABX SAS

K number K191396

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CJY 2018-10-23

Randox Calcium (Ca)

Applicant Randox Laboratories, Ltd.

K number K182042

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CJY 2013-07-03

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

Applicant HORIBA ABX SAS

K number K123171

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CJY 2012-08-22

EON CALCIUM REGENT

Applicant Vital Diagnostics (Manufacturing) Ptyltd

K number K120626

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CJY 2009-04-02

ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)

Applicant Siemens Healthcare Diagnostics

K number K083386

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CJY 2008-06-24

S-TEST CA

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K072356

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CJY 2008-02-28

CALCIUM, SCAL, NORTROL, ABTROL

Applicant Thermofisher Scientific OY

K number K073355

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CJY 2007-09-24

VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY

Applicant Ortho-Clinical Diagnostics, Inc.

K number K072443

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CJY 2007-09-20

VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)

Applicant Ortho-Clinical Diagnostics, Inc.

K number K072440

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CJY 2006-11-22

CALCIUM

Applicant Abbott Laboratories

K number K062855

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CJY 2006-10-05

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

Applicant Olympus America, Inc.

K number K061575

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CJY 2005-11-10

CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91

Applicant Diagnostic Chemicals , Ltd.

K number K051757

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CJY 2004-12-27

CALCIUM, AZO DYE REAGENT

Applicant Genchem, Inc.

K number K040972

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CJY 2002-09-10

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

Applicant Wiener Laboratories Saic

K number K021334

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CJY 2002-07-19

MODIFICATION TO RAICHEM CALCIUM REAGENT

Applicant Hemagen Diagnostics, Inc.

K number K022049

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CJY 2001-07-09

JAS CALCIUM (ARSENAZO) REAGENT

Applicant Jas Diagnostics, Inc.

K number K011441

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CJY 1998-12-17

CARESIDE CALCIUM, ORIGINAL

Applicant Careside, Inc.

K number K983789

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CJY 1998-07-29

HICHEM CALCIUM REAGENT KIT

Applicant Hichem Diagnostics

K number K981794

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CJY 1998-06-24

OLYMPUS CALCIUM ARSENAZO III REAGENT

Applicant Olympus Diagnostica GmbH

K number K982035

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CJY 1998-06-16

CA

Applicant Abbott Laboratories

K number K981578

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CJY 1998-05-18

CA

Applicant Abbott Mfg., Inc.

K number K981232

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CJY 1998-02-02

RANDOX CALCIUM

Applicant Randox Laboratories, Ltd.

K number K974607

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CJY 1996-10-10

SIGMA DIAGNOSTICS CALICIUM REAGENT

Applicant Sigma Diagnostics, Inc.

K number K963536

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CJY 1996-05-07

EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K961226

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CJY 1995-08-31

SYNERMED CALCIUM REAGENT KIT

Applicant Synermed, Inc.

K number K953395

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CJY 1994-12-06

DMA CALCIUM PLUS PROCEDURE

Applicant Data Medical Associates, Inc.

K number K944255

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CJY 1994-05-13

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808

Applicant Hi Chem, Inc.

K number K941764

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CJY 1994-03-11

SIGMA CALCIUM REAGENT

Applicant Sigma Chemical Co.

K number K933678

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CJY 1992-08-04

CALCIUM (AZ III) REAGENT

Applicant King Diagnostics, Inc.

K number K922835

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CJY 1990-07-17

CALCIUM:ARSENAZO III

Applicant Amresco, Inc.

K number K902476

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CJY 1990-04-03

COULTER CALCIUM REAGENT

Applicant Coulter Corp.

K number K900231

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CJY 1989-12-12

CALCIUM, CATALOGUE NUMBER140-20

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K895873

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CJY 1989-10-12

CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION

Applicant Catachem, Inc.

K number K894476

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CJY 1989-10-04

CALCIUM (ARSENAZO III) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K894204

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CJY 1989-08-10

BIOTROL CALCIUM MONOREACTIF

Applicant Biotrol, USA, Inc.

K number K891061

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CJY 1989-04-10

HI CHEM CALCIUM REAGENT #88808

Applicant Hichem Diagnostics

K number K890584

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CJY 1989-02-27

CALCIUM PLUS PROCEDURE

Applicant Data Medical Associates, Inc.

K number K890302

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CJY 1988-10-25

ROCHE REAGENT FOR CALCIUM

Applicant Roche Diagnostic Systems, Inc.

K number K883453

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CJY 1988-06-10

RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)

Applicant Reagents Applications, Inc.

K number K880576

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CJY 1988-04-05

SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER

Applicant Advanced Biomedical Methods, Inc.

K number K880949

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CJY 1988-03-15

KONE CALCIUM TEST

Applicant The Rupp & Bowman Co.

K number K880242

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CJY 1981-11-10

ULTRACHEM CA, ITEM #64975

Applicant Harleco

K number K813040

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CJY 1977-11-14

CALCIUM SET, ITEM NO. 65004

Applicant Harleco

K number K771928

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CJY 1977-07-11

ULTRACHEM CALCIUM

Applicant Harleco

K number K770817

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CJY 1976-11-30

AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL

Applicant Harleco

K number K761029

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