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
73–96 of 120
Cleared Aug 02, 1985
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
K853049
Simmler, Inc.
Chemistry · 14d
Cleared Jun 26, 1985
ALBUMIN
K850931
Dilab, Inc.
Chemistry · 111d
Cleared May 30, 1985
ALB BCG REAGENT
K852007
Alpkem Corp.
Chemistry · 23d
Cleared Apr 17, 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308
Technicon Instruments Corp.
Chemistry · 16d
Cleared Jan 03, 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
K844330
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Oct 11, 1984
ALBUMIN REAGENT SET
K843831
Livonia Diagnostics, Inc.
Chemistry · 10d
Cleared Sep 07, 1984
ALBUMIN ASSAY KIT
K843104
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Aug 27, 1984
SYSTEMATE ALBUMIN
K843108
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared May 01, 1984
ALBUMIN REAGENT SET
K841063
Medical Specialties, Inc.
Chemistry · 50d
Cleared Apr 13, 1984
ALBUMIN REAGENT
K840782
American Dade
Chemistry · 58d
Cleared Mar 30, 1984
MCS ALBUMIN REAGENT
K840291
Medilab Corp.
Chemistry · 66d
Cleared Jan 13, 1984
ALBUMIN REAGENT CS-716
K833699
Fisher Scientific Co., LLC
Chemistry · 87d
Cleared Oct 14, 1983
ALBUMIN REAGENT SET
K832747
Biorent Diagnostic, Inc.
Chemistry · 60d
Cleared Jun 16, 1983
ALBUMIN REAGENT (BCG
K831585
Reagents Applications, Inc.
Immunology · 30d
Cleared Mar 24, 1983
FLOW-PAC ALBUMIN REAGENT
K830536
Amresco, Inc.
Chemistry · 34d
Cleared Jan 07, 1983
COBAS REAGENT FOR ALBUMIN
K823574
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR ALBUMIN
K823575
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Sep 14, 1982
PSI ALBUMIN REAGENT
K822471
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Jul 14, 1982
ULTRA CHEM ALB
K821880
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 13, 1982
ALBUMIN REAGENT SET
K821193
Omega Medical Electronics
Chemistry · 77d
Cleared May 21, 1982
ALBUMIN REAGENT
K821225
Hi Chem, Inc.
Chemistry · 24d
Cleared Nov 10, 1981
ULTRACHEM ALB, ITEM #64970
K813044
Harleco
Chemistry · 13d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030
Eastman Kodak Company
Chemistry · 14d
Cleared Jun 25, 1981
ALBUMIN TEST
K811662
King Diagnostics, Inc.
Chemistry · 10d