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 Mar 24, 1988
WAKO(TM) AUTOKIT ALBUMIN
K880313
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Jan 11, 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070
Tech-Co, Inc.
Chemistry · 33d
Cleared Nov 23, 1987
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163
Catachem, Inc.
Chemistry · 41d
Cleared Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 29, 1987
MULTICHEM ALBUMIN REAGENT S0902
K874049
Simmler, Inc.
Chemistry · 24d
Cleared Aug 19, 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
K870372
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Sep 15, 1986
ALBUMIN PROCEDURE
K863263
Data Medical Associates, Inc.
Toxicology · 21d
Cleared Sep 11, 1986
ALBUMETER
K863050
J. D. Assoc.
Chemistry · 30d
Cleared Jun 13, 1986
ALBUMIN PROCEDURE
K861654
Data Medical Associates, Inc.
Chemistry · 44d
Cleared May 23, 1986
ALBUMIN (BCG) REAGENT
K861467
Sigma Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 17, 1986
SANDARE BCG ALBUMIN PROCEDURE
K860684
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared Mar 14, 1986
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661
Amresco, Inc.
Chemistry · 18d
Cleared Feb 19, 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Feb 11, 1986
ALBUMIN REAGENT KIT
K860213
Bio-Analytics Laboratories, Inc.
Chemistry · 20d
Cleared Jan 14, 1986
ALBUMIN REAGENT SET
K855158
Technostics Intl.
Chemistry · 19d
Cleared Dec 19, 1985
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926
K854718
Nobel Scientific Industries, Inc.
Chemistry · 27d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181
Clinical Data, Inc.
Chemistry · 41d
Cleared Oct 15, 1985
TDX AMYLASE
K853978
Abbott Laboratories
Chemistry · 19d
Cleared Sep 30, 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868
Medical Analysis Systems, Inc.
Chemistry · 13d
Cleared Aug 02, 1985
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
K853049
Simmler, Inc.
Chemistry · 14d
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