CIX · Class II · 21 CFR 862.1035

FDA Product Code CIX: Bromcresol Green Dye-binding, Albumin

Leading manufacturers include Em Diagnostic Systems, Inc., Harleco and Abbott Laboratories.

120
Total
120
Cleared
74d
Avg days
1976
Since
120 devices
25–48 of 120
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (ALB)
K913195
Eastman Kodak Company
Chemistry · 39d
Cleared Jan 25, 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
K905660
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Oct 12, 1990
SYNERMED ALBUMIN REAGENT KIT
K903543
Synermed, Inc.
Chemistry · 66d
Cleared May 30, 1990
COULTER ALBUMIN REAGENT
K901268
Coulter Corp.
Chemistry · 75d
Cleared Feb 27, 1990
COBAS READY ALBUMIN REAGENT
K896235
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Aug 21, 1989
ALBUMIN TEST (ALB) ITEM NUMBER: 65401
K893777
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared May 05, 1989
IQ ALBUMIN
K891375
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 57d
Cleared Feb 10, 1989
BIOTROL ALBUMIN
K885094
Biotrol, USA, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Apr 18, 1988
ALBUMIN CAT. # 201-03
K875207
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT ALBUMIN
K880313
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Jan 11, 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070
Tech-Co, Inc.
Chemistry · 33d
Cleared Nov 23, 1987
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163
Catachem, Inc.
Chemistry · 41d
Cleared Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 19, 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
K870372
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Sep 15, 1986
ALBUMIN PROCEDURE
K863263
Data Medical Associates, Inc.
Toxicology · 21d
Cleared Jun 13, 1986
ALBUMIN PROCEDURE
K861654
Data Medical Associates, Inc.
Chemistry · 44d
Cleared May 23, 1986
ALBUMIN (BCG) REAGENT
K861467
Sigma Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 14, 1986
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661
Amresco, Inc.
Chemistry · 18d
Cleared Feb 19, 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181
Clinical Data, Inc.
Chemistry · 41d
Cleared Oct 15, 1985
TDX AMYLASE
K853978
Abbott Laboratories
Chemistry · 19d
Cleared Sep 30, 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868
Medical Analysis Systems, Inc.
Chemistry · 13d