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
49–72 of 120
Cleared Apr 17, 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308
Technicon Instruments Corp.
Chemistry · 16d
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 Jan 13, 1984
ALBUMIN REAGENT CS-716
K833699
Fisher Scientific Co., LLC
Chemistry · 87d
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 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
Cleared Jan 09, 1981
AMES SERA-PAK ALBUMIN REAGENT KIT
K803237
Miles Laboratories, Inc.
Toxicology · 17d
Cleared Oct 31, 1980
CENTRIFICHEM ALBUMIN
K802436
Union Carbide Corp.
Chemistry · 25d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Dec 06, 1979
ELVI ALBUMIN
K792408
Volu Sol Medical Industries
Chemistry · 10d
Cleared Nov 22, 1978
ALBUMIN REAGENT
K781773
Gilford Diagnostics
Pathology · 40d
Cleared Feb 07, 1978
ULTRACHEM ALBUMIN
K780092
Harleco
Chemistry · 20d
Cleared Sep 13, 1977
MULTISTAT III ALBUMIN TEST
K771475
Instrumentation Laboratory CO
Chemistry · 40d
Cleared Jul 21, 1977
UNIPAK ALBUMIN
K771094
Harleco
Chemistry · 35d
Cleared Jul 11, 1977
ULTRACHEM ALBUMIN
K770816
Harleco
Chemistry · 68d