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
73–96 of 116
Cleared May 20, 1985
TOTAL PROTEIN LIQUID STABLE REAGENT SET
K851877
Medical Analysis Systems, Inc.
Chemistry · 21d
Cleared Jan 03, 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
K844331
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Oct 01, 1984
TOTAL PROTEIN REAGENT SET
K843701
Livonia Diagnostics, Inc.
Chemistry · 10d
Cleared Aug 27, 1984
TOTAL PROTEIN ASSAY KIT
K843028
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
SYSTEMATE TOTAL PROTEIN 67218
K843107
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared May 16, 1984
TOTAL PROTEIN REAGENT BIURET
K841466
Reagents Applications, Inc.
Chemistry · 37d
Cleared May 01, 1984
SERUM TOTAL PROTEIN REAGENT SET
K841069
Medical Specialties, Inc.
Chemistry · 50d
Cleared Apr 13, 1984
PARAMAX TOTAL PROTEIN REAGENT TP
K845052
American Dade
Chemistry · 58d
Cleared Mar 30, 1984
MCS TOTAL PROTEIN REAGENT
K840290
Medilab Corp.
Chemistry · 66d
Cleared Jan 13, 1984
TOTAL PROTEIN REAGENT CS-724
K833950
Fisher Scientific Co., LLC
Chemistry · 59d
Cleared Aug 16, 1983
TOTAL PROTEIN PROCEDURE
K832169
Sandare Chemical Co., Inc.
Chemistry · 41d
Cleared Mar 24, 1983
FLOW-PAC TOTAL PROTEIN REAGENT SET
K830538
Amresco, Inc.
Chemistry · 34d
Cleared Jan 07, 1983
COBAS REAGENT FOR TOTAL PROTEIN
K823579
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Nov 29, 1982
LIQUIZYME TOTAL PROTEIN REAGENT
K823170
Amresco, Inc.
Chemistry · 34d
Cleared Sep 14, 1982
PSI TOTAL PROTEIN REAGENT
K822468
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Jul 20, 1982
BIURET (COLORIMETRIC) TOTAL PROTEIN
K821905
American Monitor Corp.
Chemistry · 22d
Cleared Jul 13, 1982
SERUM TOTAL PROTEIN REAGENT SET
K821210
Omega Medical Electronics
Chemistry · 77d
Cleared May 03, 1982
RA-1000 SYSTEM ADD'L ANALYTES PHASE III
K820913
Technicon Instruments Corp.
Chemistry · 32d
Cleared Dec 31, 1981
ASTRA TOTAL PROTEIN REAGENT
K813536
Hi Chem, Inc.
Chemistry · 13d
Cleared Nov 27, 1981
TOTAL PROTEIN REAGENT SET
K812833
Anco Medical Reagents & Assoc.
Chemistry · 49d
Cleared Nov 10, 1981
ULTRACHEM TP, ITEM #64974
K813038
Harleco
Chemistry · 13d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
K812028
Eastman Kodak Company
Chemistry · 14d
Cleared Jun 25, 1981
TOTAL PROTEIN TEST
K811673
King Diagnostics, Inc.
Chemistry · 10d
Cleared Oct 23, 1980
IL TOTAL PROTEIN REAGENT
K802310
Instrumentation Laboratory CO
Chemistry · 30d