Atlas FDA

CJY

47 FDA 510(k) clearances · Product code

63 daysmedian time to decision
174 days90th percentile
47clearances measured

FDA profile

Official device name
Azo Dye, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 24 · 2022: 17 · 2023: 29 · 2024: 34 · 2025: 60 · 2026: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Calcium2 (K244042)Abbott Ireland2025-02-10
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396)HORIBA ABX SAS2019-07-26
Randox Calcium (Ca) (K182042)Randox Laboratories, Ltd.2018-10-23
ELITech Clinical Systems CALCIUM ARSENAZO (K151113)Elitechgroup2015-07-22
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT (K123171)HORIBA ABX SAS2013-07-03
EON CALCIUM REGENT (K120626)Vital Diagnostics (Manufacturing) Ptyltd2012-08-22
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) (K083386)Siemens Healthcare Diagnostics2009-04-02
S-TEST CA (K072356)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
CALCIUM, SCAL, NORTROL, ABTROL (K073355)Thermofisher Scientific OY2008-02-28
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (K072443)Ortho-Clinical Diagnostics, Inc.2007-09-24
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) (K072440)Ortho-Clinical Diagnostics, Inc.2007-09-20
CALCIUM (K062855)Abbott Laboratories2006-11-22
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (K061575)Olympus America, Inc.2006-10-05
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (K051757)Diagnostic Chemicals , Ltd.2005-11-10
CALCIUM, AZO DYE REAGENT (K040972)Genchem, Inc.2004-12-27
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 (K021334)Wiener Laboratories Saic2002-09-10
MODIFICATION TO RAICHEM CALCIUM REAGENT (K022049)Hemagen Diagnostics, Inc.2002-07-19
JAS CALCIUM (ARSENAZO) REAGENT (K011441)Jas Diagnostics, Inc.2001-07-09
CARESIDE CALCIUM, ORIGINAL (K983789)Careside, Inc.1998-12-17
HICHEM CALCIUM REAGENT KIT (K981794)Hichem Diagnostics1998-07-29
OLYMPUS CALCIUM ARSENAZO III REAGENT (K982035)Olympus Diagnostica GmbH1998-06-24
CA (K981578)Abbott Laboratories1998-06-16
CA (K981232)Abbott Mfg., Inc.1998-05-18
RANDOX CALCIUM (K974607)Randox Laboratories, Ltd.1998-02-02
SIGMA DIAGNOSTICS CALICIUM REAGENT (K963536)Sigma Diagnostics, Inc.1996-10-10
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE (K961226)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
SYNERMED CALCIUM REAGENT KIT (K953395)Synermed, Inc.1995-08-31
DMA CALCIUM PLUS PROCEDURE (K944255)Data Medical Associates, Inc.1994-12-06
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (K941764)Hi Chem, Inc.1994-05-13
SIGMA CALCIUM REAGENT (K933678)Sigma Chemical Co.1994-03-11
CALCIUM (AZ III) REAGENT (K922835)King Diagnostics, Inc.1992-08-04
CALCIUM:ARSENAZO III (K902476)Amresco, Inc.1990-07-17
COULTER CALCIUM REAGENT (K900231)Coulter Corp.1990-04-03
CALCIUM, CATALOGUE NUMBER140-20 (K895873)Diagnostic Chemicals, Ltd. (Usa)1989-12-12
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (K894476)Catachem, Inc.1989-10-12
CALCIUM (ARSENAZO III) REAGENT (K894204)Sigma Diagnostics, Inc.1989-10-04
BIOTROL CALCIUM MONOREACTIF (K891061)Biotrol, USA, Inc.1989-08-10
HI CHEM CALCIUM REAGENT #88808 (K890584)Hichem Diagnostics1989-04-10
CALCIUM PLUS PROCEDURE (K890302)Data Medical Associates, Inc.1989-02-27
ROCHE REAGENT FOR CALCIUM (K883453)Roche Diagnostic Systems, Inc.1988-10-25
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) (K880576)Reagents Applications, Inc.1988-06-10
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER (K880949)Advanced Biomedical Methods, Inc.1988-04-05
KONE CALCIUM TEST (K880242)The Rupp & Bowman Co.1988-03-15
ULTRACHEM CA, ITEM #64975 (K813040)Harleco1981-11-10
CALCIUM SET, ITEM NO. 65004 (K771928)Harleco1977-11-14
ULTRACHEM CALCIUM (K770817)Harleco1977-07-11
AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL (K761029)Harleco1976-11-30

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