CEK · Class II · 21 CFR 862.1635

FDA Product Code CEK: Biuret (colorimetric), Total Protein

Leading manufacturers include Em Diagnostic Systems, Inc., Harleco and Data Medical Associates, Inc..

116
Total
116
Cleared
64d
Avg days
1976
Since
116 devices
97–116 of 116
Cleared Oct 10, 1980
BIURET REAGENT & TOTAL PROTEIN BLANK SOL
K802161
Panmed, Inc.
Chemistry · 32d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
K801749
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Jul 21, 1980
TOTAL PROTEIN TEST
K801061
Environmental Chemical Specialties
Chemistry · 76d
Cleared May 28, 1980
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
K800674
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Dec 06, 1979
CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE
K792340
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
TWO MINUTE PROTEINTEST
K792346
Panmed, Inc.
Chemistry · 17d
Cleared Nov 13, 1979
SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
K792138
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Nov 05, 1979
PROTEIN ASSAY KIT
K790808
Specialty Medical Industries, Inc.
Chemistry · 193d
Cleared Jan 10, 1979
STAT KIT, MICROPROTEIN
K781897
Pierce Chemical Co.
Chemistry · 58d
Cleared Nov 22, 1978
TOTAL PROTEIN
K781774
Gilford Diagnostics
Chemistry · 40d
Cleared Nov 03, 1978
REAGENT SET, TOTAL PROTEIN
K781722
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Dec 06, 1977
ULTRACHEM TOTAL PROTEIN, #64974
K772155
Harleco
Chemistry · 20d
Cleared Nov 11, 1977
TOTAL PROTEIN SET, ITEM NO. 64010
K771926
Harleco
Chemistry · 28d
Cleared Oct 25, 1977
TOTAL PROTEIN
K771841
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Sep 12, 1977
MULTISTAT III TOTAL PROTEIN TEST
K771476
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Jul 14, 1977
AUTO TOTAL PROTEIN FOR ANALYZER
K770887
Harleco
Chemistry · 59d
Cleared May 03, 1977
PROTEIN PROCEDURE, TEKPOINT TOTAL
K770452
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared Dec 21, 1976
AUTO TOTAL PROTEIN
K761217
Harleco
Chemistry · 14d
Cleared Dec 21, 1976
AUTO TOTAL PROTEIN
K761257
Harleco
Chemistry · 14d
Cleared Oct 29, 1976
REAGENT, TOTAL PROTEIN DETERMINATION
K760480
Simmler & Son, Inc.
Chemistry · 73d