CJY · Class II · 21 CFR 862.1145

FDA Product Code CJY: Azo Dye, Calcium

Leading manufacturers include Harleco, Data Medical Associates, Inc. and Hichem Diagnostics.

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 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 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 Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049
Hemagen Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 29, 1998
HICHEM CALCIUM REAGENT KIT
K981794
Hichem Diagnostics
Chemistry · 69d
Cleared Jun 16, 1998
CA
K981578
Abbott Laboratories
Chemistry · 43d
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 Aug 31, 1995
SYNERMED CALCIUM REAGENT KIT
K953395
Synermed, Inc.
Chemistry · 44d
Cleared Dec 06, 1994
DMA CALCIUM PLUS PROCEDURE
K944255
Data Medical Associates, Inc.
Chemistry · 96d
Cleared May 13, 1994
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764
Hi Chem, Inc.
Chemistry · 45d
Cleared Mar 11, 1994
SIGMA CALCIUM REAGENT
K933678
Sigma Chemical Co.
Chemistry · 225d
Cleared Aug 04, 1992
CALCIUM (AZ III) REAGENT
K922835
King Diagnostics, Inc.
Chemistry · 53d
Cleared Jul 17, 1990
CALCIUM:ARSENAZO III
K902476
Amresco, Inc.
Chemistry · 42d
Cleared Apr 03, 1990
COULTER CALCIUM REAGENT
K900231
Coulter Corp.
Chemistry · 76d
Cleared Dec 12, 1989
CALCIUM, CATALOGUE NUMBER140-20
K895873
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Oct 12, 1989
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
K894476
Catachem, Inc.
Chemistry · 86d
Cleared Oct 04, 1989
CALCIUM (ARSENAZO III) REAGENT
K894204
Sigma Diagnostics, Inc.
Chemistry · 107d

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 →