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

FDA 510(k) Cleared Biuret (colorimetric), Total Protein Devices (Product Code CEK)

116 devices
1–24 of 116
Cleared Mar 02, 1998
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
K973108
Diagnostic Chemicals , Ltd.
Chemistry · 195d
Cleared Oct 24, 1996
CSF/URINE TOTAL PROTEIN
K961864
Teco Diagnostics
Chemistry · 163d
Cleared Jun 14, 1995
TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
K950234
Emd Chemicals, Inc.
Chemistry · 152d
Cleared May 15, 1995
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
K950128
Emd Chemicals, Inc.
Chemistry · 123d
Cleared Sep 06, 1994
DMA MICROPROTEIN PROCEDURE
K942424
Data Medical Associates, Inc.
Chemistry · 109d
Cleared Apr 06, 1994
URINARY/CEREBROSPINAL FLUID PROTEIN
K934841
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 180d
Cleared Dec 16, 1993
TOTAL PROTEIN TEST (TPRO)
K935174
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Jan 21, 1993
MICROPROTEIN REAGENT SET
K921412
Sterling Diagnostics, Inc.
Chemistry · 303d
Cleared Dec 29, 1992
OLYUMPUS TOTAL PROTEIN REAGENT
K924659
Olympus Corp.
Chemistry · 105d
Cleared Nov 23, 1992
SYNCHRON TOTAL PROTEIN TEST --MODIFIED
K922467
Beckman Instruments, Inc.
Chemistry · 193d
Cleared Sep 09, 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Aug 12, 1992
NOVA TOTAL PROTEIN MODULE
K923266
Nova Biomedical Corp.
Chemistry · 41d
Cleared Jul 16, 1992
OLYMPUS TOTAL PROTEIN REAGENT
K922361
Olympus Corp.
Chemistry · 58d
Cleared Jul 14, 1992
WAKO AUTOKIT MICRO TP
K920531
Wako Chemicals USA, Inc.
Chemistry · 160d
Cleared Feb 18, 1992
MICROPROTEIN-PR
K915380
Sigma Diagnostics, Inc.
Chemistry · 81d
Cleared Jan 30, 1992
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
K914885
Beckman Instruments, Inc.
Chemistry · 92d
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 Jan 31, 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661
Em Diagnostic Systems, Inc.
Chemistry · 44d
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 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

About Product Code CEK - Regulatory Context