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 Jul 11, 1977
A-GENT ALBUMIN
K770822
Abbott Laboratories
Chemistry · 68d
Cleared Mar 21, 1977
MT II SYSTEM - SERUM ALBUMIN
K761329
Technicon Instruments Corp.
Chemistry · 84d
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