CJY · Class II · 21 CFR 862.1145

FDA Product Code CJY: Azo Dye, Calcium

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

47
Total
47
Cleared
84d
Avg days
1976
Since
47 devices
25–47 of 47
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 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