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 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 05, 1976
TEST, SEROSONIC ALBUMIN
K760355
Mallinckrodt Critical Care
Chemistry · 64d