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
97–120 of 120
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 Oct 10, 1980
BCG REAGENT SERUM ALBUMIN W/TECHNICON
K802157
Panmed, Inc.
Chemistry · 32d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750
Beckman Instruments, Inc.
Chemistry · 50d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALBUMIN IN HUMAN
K800678
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Dec 06, 1979
CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN
K792339
Connecticut Diagnostics, Ltd.
Chemistry · 17d
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 Oct 10, 1978
BCG ALBUMIN REAGET
K781441
Analytical & Research Chemicals, Inc.
Chemistry · 50d
Cleared Feb 07, 1978
ULTRACHEM ALBUMIN
K780092
Harleco
Chemistry · 20d
Cleared Oct 25, 1977
ALBUMIN
K771828
Gamma Enterprises, Inc.
Chemistry · 26d
Cleared Sep 13, 1977
MULTISTAT III ALBUMIN TEST
K771475
Instrumentation Laboratory CO
Chemistry · 40d
Cleared Aug 22, 1977
ALBUMIN TEST, HMA ALBUMIN TEST
K771259
Hycel, Inc.
Chemistry · 42d
Cleared Jul 21, 1977
UNIPAK ALBUMIN
K771094
Harleco
Chemistry · 35d
Cleared Jul 11, 1977
ULTRACHEM ALBUMIN
K770816
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
A-GENT ALBUMIN
K770822
Abbott Laboratories
Chemistry · 68d
Cleared May 03, 1977
ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL
K770451
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared Mar 21, 1977
MT II SYSTEM - SERUM ALBUMIN
K761329
Technicon Instruments Corp.
Chemistry · 84d
Cleared Nov 30, 1976
AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL
K761026
Harleco Diagnostics
Chemistry · 18d
Cleared Nov 30, 1976
AUTO-ALBUMIN REAG FOR ABBOTT ABA-100
K761028
Harleco
Chemistry · 18d
Cleared Nov 01, 1976
BROMCRESOL GREEN
K760543
Fisher Scientific Co., LLC
Chemistry · 63d
Cleared Oct 29, 1976
REAGENT, ALBUMIN DETERMINATION
K760473
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 05, 1976
TEST, SEROSONIC ALBUMIN
K760355
Mallinckrodt Critical Care
Chemistry · 64d