FDA 510(k) Applications for Medical Device Product Code "CEK"
(Biuret (Colorimetric), Total Protein)

FDA 510(k) Number Applicant Device Name Decision Date
K884225 A-KEM, INC. TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS 12/09/1988
K860426 ABBOTT LABORATORIES A-GENT LIQUID TOTAL PROTEIN 04/03/1986
K861798 ABBOTT LABORATORIES VISION TOTAL PROTEIN 06/17/1986
K844331 ADVANCED BIOMEDICAL METHODS, INC. TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER 01/03/1985
K852006 ALPKEM CORP. TP BIURET REAGENT 06/10/1985
K845052 AMERICAN DADE PARAMAX TOTAL PROTEIN REAGENT TP 04/13/1984
K821905 AMERICAN MONITOR CORP. BIURET (COLORIMETRIC) TOTAL PROTEIN 07/20/1982
K854553 AMERICAN MONITOR CORP. TOTAL PROTEIN 11/25/1985
K852844 AMERICAN RESEARCH PRODUCTS CO. AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC 07/22/1985
K901527 AMERICAN RESEARCH PRODUCTS CO. BIURET (COLORMETRIC), TOTAL PROTEIN 07/19/1990
K830538 AMRESCO, INC. FLOW-PAC TOTAL PROTEIN REAGENT SET 03/24/1983
K823170 AMRESCO, INC. LIQUIZYME TOTAL PROTEIN REAGENT 11/29/1982
K812833 ANCO MEDICAL REAGENTS & ASSOC. TOTAL PROTEIN REAGENT SET 11/27/1981
K801749 BECKMAN INSTRUMENTS, INC. BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM 09/16/1980
K914885 BECKMAN INSTRUMENTS, INC. BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST 01/30/1992
K922467 BECKMAN INSTRUMENTS, INC. SYNCHRON TOTAL PROTEIN TEST --MODIFIED 11/23/1992
K913978 BECKMAN INSTRUMENTS, INC. TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE 10/09/1991
K905790 BIOCHEMICAL TRADE, INC. TOTAL PROTEIN REAGENT SET 02/21/1991
K882189 BIOTROL, USA, INC. BIOTROL TOTAL PROTEIN H.P. 07/01/1988
K971524 CAROLINA LIQUID CHEMISTRIES CORP. TOTAL PROTEIN OR TP 05/16/1997
K875222 CATACHEM, INC. TOTAL PROTEIN 01/22/1988
K792340 CONNECTICUT DIAGNOSTICS, LTD. CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE 12/06/1979
K863301 COOPERBIOMEDICAL, INC. DEMAND TOTAL PROTEIN 09/26/1986
K897166 COULTER ELECTRONICS, INC. COULTER TOTAL PROTEIN REAGENT 02/23/1990
K942424 DATA MEDICAL ASSOCIATES, INC. DMA MICROPROTEIN PROCEDURE 09/06/1994
K890868 DATA MEDICAL ASSOCIATES, INC. DMA MICROPROTEIN PROCEDURE 03/20/1989
K863258 DATA MEDICAL ASSOCIATES, INC. TOTAL PROTEIN PROCEDURE 09/29/1986
K861663 DATA MEDICAL ASSOCIATES, INC. TOTAL PROTEIN PROCEDURE 06/13/1986
K955936 DERMA MEDIA LAB., INC. TOTAL PROTEIN REAGENT 03/12/1996
K973108 DIAGNOSTIC CHEMICALS LTD. TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 03/02/1998
K843028 DIAGNOSTIC CHEMICALS, LTD. (USA) TOTAL PROTEIN ASSAY KIT 08/27/1984
K800674 DIAGNOSTIC SOLUTIONS, INC. SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER 05/28/1980
K850936 DILAB, INC. TOTAL PROTEINS 06/25/1985
K950920 DUPONT MEDICAL PRODUCTS DUPONT DIMENSION TOTAL PROTEIN METHOD 08/11/1995
K934841 E.I. DUPONT DE NEMOURS & CO., INC. URINARY/CEREBROSPINAL FLUID PROTEIN 04/06/1994
K812028 EASTMAN KODAK COMPANY KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) 08/03/1981
K881639 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) 07/08/1988
K992846 ELAN HOLDINGS, INC. HICHEM TOTAL PROTEIN REAGENT 10/18/1999
K900733 ELITE TECHNOLOGY, INC. PROTEIN TEST FOR URINE AND CSF 07/10/1990
K912810 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 07/30/1991
K874476 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 11/25/1987
K860917 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST TOTAL PROTEIN (TP), #67513/93 04/07/1986
K893915 EM DIAGNOSTIC SYSTEMS, INC. EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 08/31/1989
K863005 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 08/29/1986
K905661 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 01/31/1991
K843107 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE TOTAL PROTEIN 67218 08/27/1984
K923267 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 09/09/1992
K884703 EM DIAGNOSTIC SYSTEMS, INC. TOTAL PROTEIN TEST (TP) ITEM #65670 01/23/1989
K935174 EM DIAGNOSTIC SYSTEMS, INC. TOTAL PROTEIN TEST (TPRO) 12/16/1993
K950234 EMD CHEMICALS INC. TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 06/14/1995
K950128 EMD CHEMICALS INC. TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 05/15/1995
K801061 ENVIRONMENTAL CHEMICAL SPECIALTIES TOTAL PROTEIN TEST 07/21/1980
K980042 EXIGENT DIAGNOSTICS, INC. CARESIDE TOTAL PROTEIN 02/04/1998
K792138 FISHER SCIENTIFIC CO., LLC. SMAC (SEQUENTIAL MULT. ANALYSIS COMP. 11/13/1979
K833950 FISHER SCIENTIFIC CO., LLC. TOTAL PROTEIN REAGENT CS-724 01/13/1984
K771841 GAMMA ENTERPRISES, INC. TOTAL PROTEIN 10/25/1977
K781774 GILFORD DIAGNOSTICS TOTAL PROTEIN 11/22/1978
K761217 HARLECO AUTO TOTAL PROTEIN 12/21/1976
K761257 HARLECO AUTO TOTAL PROTEIN 12/21/1976
K770887 HARLECO AUTO TOTAL PROTEIN FOR ANALYZER 07/14/1977
K771926 HARLECO TOTAL PROTEIN SET, ITEM NO. 64010 11/11/1977
K772155 HARLECO ULTRACHEM TOTAL PROTEIN, #64974 12/06/1977
K813038 HARLECO ULTRACHEM TP, ITEM #64974 11/10/1981
K896916 HERAEUS KULZER, INC. CLINISTAT TOTAL PROTEIN REAGENT TEST 01/19/1990
K813536 HI CHEM, INC. ASTRA TOTAL PROTEIN REAGENT 12/31/1981
K823579 HOFFMANN-LA ROCHE, INC. COBAS REAGENT FOR TOTAL PROTEIN 01/07/1983
K770452 ICN PHARMACEUTICALS, INC. PROTEIN PROCEDURE, TEKPOINT TOTAL 05/03/1977
K802310 INSTRUMENTATION LABORATORY CO. IL TOTAL PROTEIN REAGENT 10/23/1980
K771476 INSTRUMENTATION LABORATORY CO. MULTISTAT III TOTAL PROTEIN TEST 09/12/1977
K913225 INTERSECT SYSTEMS, INC. URINE/CSF MICROPROTEIN REAGENT 10/11/1991
K863074 J. D. ASSOC. TOTAL PROTEINS 09/09/1986
K890618 KENLOR INDUSTRIES, INC. COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT 05/22/1989
K811673 KING DIAGNOSTICS, INC. TOTAL PROTEIN TEST 06/25/1981
K843701 LIVONIA DIAGNOSTICS, INC. TOTAL PROTEIN REAGENT SET 10/01/1984
K781722 MEDICAL ANALYSIS SYSTEMS, INC. REAGENT SET, TOTAL PROTEIN 11/03/1978
K851877 MEDICAL ANALYSIS SYSTEMS, INC. TOTAL PROTEIN LIQUID STABLE REAGENT SET 05/20/1985
K890317 MEDICAL ANALYSIS SYSTEMS, INC. TOTAL PROTEIN REAGENT 03/08/1989
K841069 MEDICAL SPECIALTIES, INC. SERUM TOTAL PROTEIN REAGENT SET 05/01/1984
K840290 MEDILAB CORP. MCS TOTAL PROTEIN REAGENT 03/30/1984
K854717 NOBEL SCIENTIFIC INDUSTRIES, INC. NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 01/14/1986
K923266 NOVA BIOMEDICAL CORP. NOVA TOTAL PROTEIN MODULE 08/12/1992
K922361 OLYMPUS CORP. OLYMPUS TOTAL PROTEIN REAGENT 07/16/1992
K924659 OLYMPUS CORP. OLYUMPUS TOTAL PROTEIN REAGENT 12/29/1992
K821210 OMEGA MEDICAL ELECTRONICS SERUM TOTAL PROTEIN REAGENT SET 07/13/1982
K802161 PANMED, INC. BIURET REAGENT & TOTAL PROTEIN BLANK SOL 10/10/1980
K792346 PANMED, INC. TWO MINUTE PROTEINTEST 12/06/1979
K781897 PIERCE CHEMICAL CO. STAT KIT, MICROPROTEIN 01/10/1979
K822468 POINTE SCIENTIFIC, INC. PSI TOTAL PROTEIN REAGENT 09/14/1982
K943004 PRISMA SYSTEMS TOTAL PROTEIN QVET 12/09/1994
K853930 QUANTIMETRIX CORP. QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT 12/10/1985
K853932 QUANTIMETRIX CORP. QUANTTEST TOTAL PROTEIN ASSAY 12/19/1985
K904603 QUANTITATIVE MEDICINE, INC. QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM 01/25/1991
K841466 REAGENTS APPLICATIONS, INC. TOTAL PROTEIN REAGENT BIURET 05/16/1984
K896230 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY TOTAL PROTEIN REAGENT 02/16/1990
K832169 SANDARE CHEMICAL CO., INC. TOTAL PROTEIN PROCEDURE 08/16/1983
K890278 SIGMA CHEMICAL CO. TOTAL PROTEIN REAGENT 03/09/1989
K915380 SIGMA DIAGNOSTICS, INC. MICROPROTEIN-PR 02/18/1992
K853681 SIGMA DIAGNOSTICS, INC. SIGMA 610 FOR PROTEIN IN URINE & CSF 10/28/1985
K760480 SIMMLER & SON, INC. REAGENT, TOTAL PROTEIN DETERMINATION 10/29/1976
K871975 SIMMLER, INC. MULTICHEM TOTAL PROTEIN REAGENT #S0928 06/05/1987
K853244 SIMMLER, INC. TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE 08/12/1985
K955905 SOLARCARE TECHNOLOGIES CORP,INC. STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY 05/30/1996
K941496 SOLARCARE, INC. SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY 10/27/1994
K790808 SPECIALTY MEDICAL INDUSTRIES, INC. PROTEIN ASSAY KIT 11/05/1979
K921412 STERLING DIAGNOSTICS, INC. MICROPROTEIN REAGENT SET 01/21/1993
K860341 STERLING DIAGNOSTICS, INC. TOTAL PROTEIN (BIURET) REAGENT SET 02/11/1986
K903511 SYNERMED, INC. SYNERMED TOTAL PROTEIN REAGENT KIT 09/07/1990
K864743 TECH-CO, INC. BIURET (COLORIMETRIC), TOTAL PROTEIN 01/13/1987
K880677 TECH-NEAL SCIENTIFIC, INC. TOTAL PROTEIN REAGENT SET 03/24/1988
K820913 TECHNICON INSTRUMENTS CORP. RA-1000 SYSTEM ADD'L ANALYTES PHASE III 05/03/1982
K855191 TECHNOSTICS INTL. TOTAL PROTEIN REAGENT SET 01/14/1986
K961864 TECO DIAGNOSTICS CSF/URINE TOTAL PROTEIN 10/24/1996
K870371 TRACE SCIENTIFIC LTD. TOTAL PROTEIN REAGENT - BIURET METHOD 08/19/1987
K920531 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT MICRO TP 07/14/1992
K861508 WAKO CHEMICALS, USA, INC. WAKO MICRO TP 08/19/1986
K880312 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT TOTAL PROTEIN 03/24/1988


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