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
25–48 of 116
Cleared Oct 11, 1991
URINE/CSF MICROPROTEIN REAGENT
K913225
Intersect Systems, Inc.
Chemistry · 84d
Cleared Oct 09, 1991
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
K913978
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Feb 21, 1991
TOTAL PROTEIN REAGENT SET
K905790
Biochemical Trade, Inc.
Chemistry · 56d
Cleared Jan 31, 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Jan 25, 1991
QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
K904603
Quantitative Medicine, Inc.
Chemistry · 107d
Cleared Sep 07, 1990
SYNERMED TOTAL PROTEIN REAGENT KIT
K903511
Synermed, Inc.
Chemistry · 35d
Cleared Jul 19, 1990
BIURET (COLORMETRIC), TOTAL PROTEIN
K901527
American Research Products Co.
Chemistry · 108d
Cleared Jul 10, 1990
PROTEIN TEST FOR URINE AND CSF
K900733
Elite Technology, Inc.
Chemistry · 144d
Cleared Feb 23, 1990
COULTER TOTAL PROTEIN REAGENT
K897166
Coulter Electronics, Inc.
Chemistry · 57d
Cleared Feb 16, 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Jan 19, 1990
CLINISTAT TOTAL PROTEIN REAGENT TEST
K896916
Heraeus Kulzer, Inc.
Chemistry · 39d
Cleared Aug 31, 1989
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared May 22, 1989
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
K890618
Kenlor Industries, Inc.
Chemistry · 104d
Cleared Mar 20, 1989
DMA MICROPROTEIN PROCEDURE
K890868
Data Medical Associates, Inc.
Chemistry · 27d
Cleared Mar 09, 1989
TOTAL PROTEIN REAGENT
K890278
Sigma Chemical Co.
Chemistry · 50d
Cleared Mar 08, 1989
TOTAL PROTEIN REAGENT
K890317
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Jan 23, 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Dec 09, 1988
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
K884225
A-Kem, Inc.
Chemistry · 64d
Cleared Jul 08, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
K881639
Eastman Kodak Company
Chemistry · 85d
Cleared Jul 01, 1988
BIOTROL TOTAL PROTEIN H.P.
K882189
Biotrol, USA, Inc.
Chemistry · 38d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
K880312
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
TOTAL PROTEIN REAGENT SET
K880677
Tech-Neal Scientific, Inc.
Chemistry · 34d
Cleared Jan 22, 1988
TOTAL PROTEIN
K875222
Catachem, Inc.
Chemistry · 31d