CEK · Class II · 21 CFR 862.1635

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

Leading manufacturers include Em Diagnostic Systems, Inc., Beckman Instruments, Inc. and Instrumentation Laboratory CO.

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 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 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 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 Feb 16, 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Aug 31, 1989
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Mar 09, 1989
TOTAL PROTEIN REAGENT
K890278
Sigma Chemical Co.
Chemistry · 50d
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 Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 29, 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Jun 17, 1986
VISION TOTAL PROTEIN
K861798
Abbott Laboratories
Chemistry · 39d
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 Aug 27, 1984
SYSTEMATE TOTAL PROTEIN 67218
K843107
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
K812028
Eastman Kodak Company
Chemistry · 14d
Cleared Oct 23, 1980
IL TOTAL PROTEIN REAGENT
K802310
Instrumentation Laboratory CO
Chemistry · 30d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
K801749
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Sep 12, 1977
MULTISTAT III TOTAL PROTEIN TEST
K771476
Instrumentation Laboratory CO
Chemistry · 39d

About Product Code CEK - Regulatory Context