CJY · Class II · 21 CFR 862.1145

FDA Product Code CJY: Azo Dye, Calcium

Leading manufacturers include Harleco, Sigma Diagnostics, Inc. and Ortho-Clinical Diagnostics, Inc..

47
Total
47
Cleared
84d
Avg days
1976
Since
47 devices
25–47 of 47
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
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
Cleared Aug 10, 1989
BIOTROL CALCIUM MONOREACTIF
K891061
Biotrol, USA, Inc.
Chemistry · 162d
Cleared Apr 10, 1989
HI CHEM CALCIUM REAGENT #88808
K890584
Hichem Diagnostics
Chemistry · 63d
Cleared Feb 27, 1989
CALCIUM PLUS PROCEDURE
K890302
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Oct 25, 1988
ROCHE REAGENT FOR CALCIUM
K883453
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Jun 10, 1988
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576
Reagents Applications, Inc.
Chemistry · 121d
Cleared Apr 05, 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K880949
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 15, 1988
KONE CALCIUM TEST
K880242
The Rupp & Bowman Co.
Chemistry · 55d
Cleared Nov 10, 1981
ULTRACHEM CA, ITEM #64975
K813040
Harleco
Chemistry · 13d
Cleared Nov 14, 1977
CALCIUM SET, ITEM NO. 65004
K771928
Harleco
Chemistry · 31d
Cleared Jul 11, 1977
ULTRACHEM CALCIUM
K770817
Harleco
Chemistry · 68d
Cleared Nov 30, 1976
AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL
K761029
Harleco
Chemistry · 18d