CJY · Class II · 21 CFR 862.1145

FDA Product Code CJY: Azo Dye, Calcium

Leading manufacturers include Harleco, Ortho-Clinical Diagnostics, Inc. and HORIBA ABX SAS.

47
Total
47
Cleared
84d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 42d recently vs 85d historically

FDA 510(k) Cleared Azo Dye, Calcium Devices (Product Code CJY)

47 devices
1–24 of 47
Cleared Feb 10, 2025
Calcium2
K244042
Abbott Ireland
Chemistry · 42d
Cleared Jul 26, 2019
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K191396
HORIBA ABX SAS
Chemistry · 63d
Cleared Oct 23, 2018
Randox Calcium (Ca)
K182042
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Jul 22, 2015
ELITech Clinical Systems CALCIUM ARSENAZO
K151113
Elitechgroup
Chemistry · 86d
Cleared Jul 03, 2013
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 SAS
Chemistry · 267d
Cleared Aug 22, 2012
EON CALCIUM REGENT
K120626
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 174d
Cleared Apr 02, 2009
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
K083386
Siemens Healthcare Diagnostics
Chemistry · 136d
Cleared Jun 24, 2008
S-TEST CA
K072356
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 307d
Cleared Sep 24, 2007
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
K072443
Ortho-Clinical Diagnostics, Inc.
Chemistry · 25d
Cleared Sep 20, 2007
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
K072440
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Nov 22, 2006
CALCIUM
K062855
Abbott Laboratories
Chemistry · 58d
Cleared Oct 05, 2006
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
K061575
Olympus America, Inc.
Chemistry · 120d
Cleared Nov 10, 2005
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
K051757
Diagnostic Chemicals , Ltd.
Chemistry · 134d
Cleared Sep 10, 2002
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 Saic
Chemistry · 137d
Cleared Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049
Hemagen Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 09, 2001
JAS CALCIUM (ARSENAZO) REAGENT
K011441
Jas Diagnostics, Inc.
Chemistry · 60d
Cleared Dec 17, 1998
CARESIDE CALCIUM, ORIGINAL
K983789
Careside, Inc.
Chemistry · 51d
Cleared Jul 29, 1998
HICHEM CALCIUM REAGENT KIT
K981794
Hichem Diagnostics
Chemistry · 69d
Cleared Jun 24, 1998
OLYMPUS CALCIUM ARSENAZO III REAGENT
K982035
Olympus Diagnostica GmbH
Chemistry · 14d
Cleared Jun 16, 1998
CA
K981578
Abbott Laboratories
Chemistry · 43d
Cleared May 18, 1998
CA
K981232
Abbott Mfg., Inc.
Chemistry · 45d
Cleared Feb 02, 1998
RANDOX CALCIUM
K974607
Randox Laboratories, Ltd.
Chemistry · 54d
Cleared Oct 10, 1996
SIGMA DIAGNOSTICS CALICIUM REAGENT
K963536
Sigma Diagnostics, Inc.
Chemistry · 37d
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
K961226
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 39d

About Product Code CJY - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code CJY since 1976, with 47 receiving FDA clearance (average review time: 84 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - CJY Product Code

Recent submissions under CJY have taken an average of 42 days to reach a decision - down from 85 days historically, suggesting improved FDA processing for this classification.

CJY devices are reviewed by the Chemistry panel. Browse all Chemistry devices →