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 Feb 04, 1998
CARESIDE ALBUMIN
K980041
Exigent Diagnostics, Inc.
Chemistry · 29d
Cleared May 02, 1997
ALB OR ALBUMIN
K971445
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared Mar 13, 1996
ALBUMIN
K955781
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Oct 13, 1995
TRACE COBAS MIRA RANGE
K952488
Trace Scientific , Ltd.
Chemistry · 136d
Cleared Mar 01, 1995
DMA ALBUMIN PROCEDURE
K946355
Data Medical Associates, Inc.
Chemistry · 61d
Cleared Dec 13, 1994
ALBUMIN QVET
K943000
Prisma Systems
Chemistry · 173d
Cleared Dec 17, 1993
EMDS ALBUMIN (ALB) TEST
K935179
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Feb 08, 1993
OLYMPUS ALBUMIN REAGENT
K924368
Olympus Corp.
Chemistry · 164d
Cleared Dec 28, 1992
ALBUMIN TEST
K923959
Em Diagnostic Systems, Inc.
Chemistry · 144d
Cleared Sep 11, 1992
TRACE ALBUMIN-MR REAGENT
K923322
Trace Scientific , Ltd.
Hematology · 66d
Cleared Jul 17, 1992
OLYMPUS ALBUMIN REAGENT
K922369
Olympus Corp.
Chemistry · 58d
Cleared Nov 27, 1991
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888
Technicon Instruments Corp.
Chemistry · 28d
Cleared Sep 27, 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920
Em Diagnostic Systems, Inc.
Chemistry · 24d
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 Apr 05, 1988
ALBUMIN REAGENT SET
K880844
Tech-Neal Scientific, Inc.
Chemistry · 39d