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
49–72 of 116
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 Jun 05, 1987
MULTICHEM TOTAL PROTEIN REAGENT #S0928
K871975
Simmler, Inc.
Chemistry · 14d
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 Sep 26, 1986
DEMAND TOTAL PROTEIN
K863301
Cooper Biomedical, Inc.
Chemistry · 32d
Cleared Sep 09, 1986
TOTAL PROTEINS
K863074
J. D. Assoc.
Chemistry · 28d
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 Jan 14, 1986
NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928
K854717
Nobel Scientific Industries, Inc.
Chemistry · 53d
Cleared Jan 14, 1986
TOTAL PROTEIN REAGENT SET
K855191
Technostics Intl.
Chemistry · 19d
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
Cleared Aug 12, 1985
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
K853244
Simmler, Inc.
Chemistry · 11d
Cleared Jul 22, 1985
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
K852844
American Research Products Co.
Chemistry · 17d
Cleared Jun 25, 1985
TOTAL PROTEINS
K850936
Dilab, Inc.
Chemistry · 110d
Cleared Jun 10, 1985
TP BIURET REAGENT
K852006
Alpkem Corp.
Chemistry · 34d