CEK · Class II · 21 CFR 862.1635

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

Leading manufacturers include Em Diagnostic Systems, Inc., Harleco and Beckman Instruments, Inc..

116
Total
116
Cleared
64d
Avg days
1976
Since
116 devices
25–48 of 116
Cleared Aug 31, 1989
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915
Em Diagnostic Systems, Inc.
Chemistry · 93d
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 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 Jan 22, 1988
TOTAL PROTEIN
K875222
Catachem, Inc.
Chemistry · 31d
Cleared Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 19, 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Jan 13, 1987
BIURET (COLORIMETRIC), TOTAL PROTEIN
K864743
Tech-Co, Inc.
Chemistry · 40d
Cleared Sep 29, 1986
TOTAL PROTEIN PROCEDURE
K863258
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Aug 29, 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Aug 19, 1986
WAKO MICRO TP
K861508
Wako Chemicals USA, Inc.
Chemistry · 118d
Cleared Jun 17, 1986
VISION TOTAL PROTEIN
K861798
Abbott Laboratories
Chemistry · 39d
Cleared Jun 13, 1986
TOTAL PROTEIN PROCEDURE
K861663
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Apr 07, 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL PROTEIN
K860426
Abbott Laboratories
Chemistry · 58d
Cleared Feb 11, 1986
TOTAL PROTEIN (BIURET) REAGENT SET
K860341
Sterling Diagnostics, Inc.
Chemistry · 13d
Cleared Dec 19, 1985
QUANTTEST TOTAL PROTEIN ASSAY
K853932
Quantimetrix Corp.
Chemistry · 86d
Cleared Dec 10, 1985
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT
K853930
Quantimetrix Corp.
Chemistry · 77d
Cleared Nov 25, 1985
TOTAL PROTEIN
K854553
American Monitor Corp.
Chemistry · 12d
Cleared Oct 28, 1985
SIGMA 610 FOR PROTEIN IN URINE & CSF
K853681
Sigma Diagnostics, Inc.
Chemistry · 54d