FDA 510(k) Applications for Medical Device Product Code "CJE"
(Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)

FDA 510(k) Number Applicant Device Name Decision Date
K991762 A.P. TOTAL CARE, INC. ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 09/02/1999
K890521 ABBOTT LABORATORIES ABBOTT CLINICAL CHEMISTRY REAGENT ALP 03/24/1989
K981245 ABBOTT LABORATORIES ALKALINE PHOSPHATASE (ALKP) 05/20/1998
K981806 ABBOTT LABORATORIES ALKP 06/22/1998
K023807 ABBOTT LABORATORIES MODIFICATION TO ALKP 12/26/2002
K850110 ABBOTT LABORATORIES VISION -FORMERLY PDA- ALKALINE PHOSPHATASE 01/29/1985
K852784 ADVANCED BIOMEDICAL METHODS, INC. ALKALINE PHOSPHATASE 07/22/1985
K113436 ALFA WASSERMANN ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT 07/12/2012
K131351 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT 08/15/2013
K851998 ALPKEM CORP. ALP(ALKALINE)(PHOSPHATASE) REAGENT 05/30/1985
K831480 AMERICAN DADE PARAMAX ALKALINE PHOSPHATASE REAGENT- 06/22/1983
K834033 AMERICAN MONITOR CORP. KINETIC ALKALINE PHOSPHATASE 01/30/1984
K900250 AMERICAN RESEARCH PRODUCTS CO. AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781 03/01/1990
K852752 AMERICAN RESEARCH PRODUCTS CO. AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE 07/23/1985
K905684 AMRESCO, INC. ALKALINE PHOSPHATASE 12/28/1990
K823786 ANALYTICAL & RESEARCH CHEMICALS, INC. ALKALINE PHOSPHATASE 01/14/1983
K802574 BECKMAN INSTRUMENTS, INC. BECKMAN LIQUID STAT LIQUID/ALKALINE PHO 11/12/1980
K781472 BECKMAN INSTRUMENTS, INC. MITROPHENYL, ALKALINE PHOSPHATES 09/27/1978
K810082 BIO-ANALYTICS LABORATORIES, INC. ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT 01/26/1981
K861638 BIO-ANALYTICS LABORATORIES, INC. KINETIC ALKALINE PHOSPHATASE REAGENT KIT 05/29/1986
K905650 BIOCHEMICAL TRADE, INC. KINETIC ALKALINE PHOSPHATASE DETERMINATION 02/13/1991
K881742 BIOTROL, USA, INC. BIOTROL ALKALINE PHOSPHATASE 07/08/1988
K770406 BOEHRINGER LABORATORIES TECHNICON SMA & AAII SYSTEMS 06/02/1977
K823213 BOEHRINGER MANNHEIM CORP. DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI 11/22/1982
K990024 CARESIDE, INC. CARESIDE ALKALINE PHOSPHATASE 01/13/1999
K971463 CAROLINA LIQUID CHEMISTRIES CORP. ALP REAGENT SET 05/16/1997
K871543 CATACHEM, INC. ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. 06/22/1987
K852441 CLINICAL DATA, INC. IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN 08/21/1985
K900216 COULTER CORP. COULTER ALP (ALK PHOS) REAGENT 02/08/1990
K861667 DATA MEDICAL ASSOCIATES, INC. ALKALINE PHOSPHATASE PROCEDURE 05/29/1986
K863268 DATA MEDICAL ASSOCIATES, INC. ALKALINE PHOSPHATASE PROCEDURE 09/29/1986
K831360 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME ALKALINE PHOSPHATASE PROCED 06/08/1983
K964914 DERMA MEDIA LAB., INC. ALKALINE PHOSPHATASE 02/04/1997
K980316 DIAGNOSTIC CHEMICALS LTD. ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 02/12/1998
K003093 DIAGNOSTIC CHEMICALS LTD. ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 11/27/2000
K842243 DIAGNOSTIC CHEMICALS, LTD. (USA) ALKALINE PHOSPHATASE ASSAY KIT 07/18/1984
K875210 DIAGNOSTIC CHEMICALS, LTD. (USA) ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 02/02/1988
K800679 DIAGNOSTIC SOLUTIONS, INC. REAGENTS FOR DETERM. ALKALINE PHOSPHATAS 05/28/1980
K002285 ELAN DIAGNOSTICS ATAC PAK ALP REAGENT KIT 09/26/2000
K991387 ELAN HOLDINGS, INC. ELAN ALKALINE PHOSPHATE REAGENT KIT 05/19/1999
K113269 ELITECHGROUP ELITTECH CLINICAL SYSTEMS ALP IFCC SL 12/29/2011
K913921 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 11/22/1991
K873681 EM DIAGNOSTIC SYSTEMS, INC. ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 09/29/1987
K884549 EM DIAGNOSTIC SYSTEMS, INC. ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 11/10/1988
K873635 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 10/29/1987
K860134 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT 02/06/1986
K924574 EM DIAGNOSTIC SYSTEMS, INC. EMDS ALKALINE PHOSPHATASE (ALP) TEST 11/09/1992
K935182 EM DIAGNOSTIC SYSTEMS, INC. EMDS ALKANINE PHOSPHATASE (ALP) TEST 12/09/1993
K910639 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 04/12/1991
K843270 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE ALKALINE PHOSPHATASE-67203 09/13/1984
K895250 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 10/31/1989
K821471 EMD CHEMICALS INC. ULTRAZYME PLUS ALP #64962,65029&65030 06/02/1982
K781609 FISHER SCIENTIFIC CO., LLC. ALKALINE PHOSPHATASE IN SERUM 10/24/1978
K771829 GAMMA ENTERPRISES, INC. ALKALINE PHOSPHATASE 11/02/1977
K812912 GILFORD DIAGNOSTICS GILCHEM ALP REAGENT 11/02/1981
K772032 HARLECO GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP 11/17/1977
K812596 HARLECO ULTRA ZYME PLUS ALP #64962, 65029 & 30 09/29/1981
K760024 HARLECO ULTRAZYME ALKALINE PHOSPHATASE 08/26/1976
K770870 HARLECO ULTRAZYME PLUS ALP 07/14/1977
K780095 HARLECO ULTRAZYME PLUS ALP 02/13/1978
K821870 HARLECO DIAGNOSTICS ULTRAZYME PLUS ALP 07/13/1982
K861284 HI CHEM, INC. AP REAGENT CARTRIDGE 04/28/1986
K130141 HITACHI CHEMICAL DIAGNOSTICS, INC. S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) 03/22/2013
K060205 HORIBA ABX GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER 07/21/2006
K770316 ICN PHARMACEUTICALS, INC. ALKALINE PHOSPHATASE ENZYMATIC 03/30/1977
K771470 INSTRUMENTATION LABORATORY CO. MULTISTAT III ALKALINE PHOSPHATASE 09/12/1977
K863051 J. D. ASSOC. ALP S.C.E. 09/09/1986
K771085 J.T. BAKER CHEMICAL CO. DYNAZYME II ALKALINE PHOSPHATASE 08/04/1977
K760397 J.T. BAKER CHEMICAL CO. REAGENT, AMP BUFFER DIAGNOSTIC 11/01/1976
K760398 J.T. BAKER CHEMICAL CO. REAGENT, MAGNESIUM CHLORIDE 10/29/1976
K760399 J.T. BAKER CHEMICAL CO. REAGENT, P-NITROPHENYL PHOSPHATE 08/26/1976
K011599 JAS Diagnostics, Inc. ALKALINE PHOSPHATASE LIQUID REAGENT 07/20/2001
K862498 KING DIAGNOSTICS, INC. ALKALINE PHOSPHATASE TEST 09/26/1986
K171971 Lite-On Technology Corp. H.S.P.B. Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer 01/25/2018
K790065 MACOMB CHEMICAL CO. ALKALINE PHOSPHATASE 02/21/1979
K101090 MEDICA CORP. EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS 05/20/2011
K780068 MEDICAL ANALYSIS SYSTEMS, INC. ALP REAGENT SET 02/07/1978
K781718 MEDICAL ANALYSIS SYSTEMS, INC. ALP REAGENT SET, ALKALINE PHOSPHATASE 11/03/1978
K952746 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. ALKALINE PHOSPHATASE REAGENT SYSTEM 11/27/1995
K925156 OLYMPUS CORP. OLYMPUS ALKALINE PHOSPHATASE REAGENT 11/18/1992
K923527 OLYMPUS CORP. OLYMPUS ALKALINE PHOSPHATASE REAGENT 09/28/1992
K812452 POINTE SCIENTIFIC, INC. ALKALINE PHOSPHATASE 09/09/1981
K973588 POINTE SCIENTIFIC, INC. LIQUID ALKALINE PHOSHATASE REAGENT SET 10/22/1997
K761315 PRINCETON BIOMEDIX ALKALINE PHOSPHATASE (ALP)/PNPP 02/24/1977
K942997 PRISMA SYSTEMS ALKALINE PHOSPHATASE (ALKP) QVET 12/29/1994
K162275 RANDOX LABORATORIES LIMITED Randox RX Daytona Plus Alkaline Phosphatase (ALP) 04/21/2017
K923507 RANDOX LABORATORIES, LTD. ALKALINE PHOSPHATASE KIT 12/03/1992
K832463 REAGENTS APPLICATIONS, INC. RAICHEM ALKALINE PHOSPHATASE REAGENT 09/12/1983
K801242 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENT FOR ALKALINE PHOSPHATASE 06/20/1980
K981897 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE 08/26/1998
K902560 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT 07/17/1990
K033185 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA ALP IFCC GEN.2 10/14/2003
K171080 Roche Diagnostics Operations (RDO) ALP IFCC Gen.2 05/10/2017
K771695 SCLAVO, INC. ALKALINE PHOSPHATASE TEST 10/18/1977
K833744 SERAGEN DIAGNOSTICS, INC. ALKALINE PHOSPHATASE-RATE 01/13/1984
K760685 SIGMA CHEMICAL CO. SIGMA PROCED #SC165 11/24/1976
K954840 SIGMA DIAGNOSTICS, INC. ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 02/28/1996
K951584 SIGMA DIAGNOSTICS, INC. ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 08/11/1995
K862905 SIGMA DIAGNOSTICS, INC. ALP (OPT) REAGENT 08/29/1986
K841918 SIGMA DIAGNOSTICS, INC. SIGMA PROCED. 245 ALKALINE PHOSPHATASE 06/14/1984
K760474 SIMMLER & SON, INC. REAGENT, ALKALINE PHOSPHATASE DETERM. 10/29/1976
K873761 SIMMLER, INC. MULTICHEM ALKALINE PHOSPHATASE (S0903) 10/07/1987
K941313 STANBIO LABORATORY STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET 05/17/1994
K843332 STERLING BIOCHEMICAL, INC. ALKALINE PHOSPHATASE REAGENT SET 09/14/1984
K862256 STERLING DIAGNOSTICS, INC. ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET 07/01/1986
K931986 SYNERMED, INC. AMP ALKALINE PHOSPHATASE REAGENT KIT 09/08/1993
K904030 SYNERMED, INC. SYNERMED ALKALINE PHOSPHATASE REAGENT KIT 09/27/1990
K864905 TECH-CO, INC. ALKALINE PHOSPHATASE 01/13/1987
K880307 TECH-NEAL SCIENTIFIC, INC. ALKALINE PHOSPHATASE REAGENT SET 03/15/1988
K000067 TECO DIAGNOSTICS ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H 01/20/2000
K012518 THERMO DMA, INC. TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 10/09/2001
K073191 THERMO FISHER SCIENTIFIC OY ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL 02/28/2008
K880796 TRACE AMERICA, INC. ALKALINE PHOSPHATASE REAGENT, DEA BUFF 04/18/1988
K880795 TRACE AMERICA, INC. RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. 04/18/1988
K860715 TRACE SCIENTIFIC LTD. ALP (ALKALINE PHOSPHATASE) REAGENT 04/24/1986
K863980 U. S. DIAGNOSTICS, INC. U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST 12/04/1986
K800131 UNION CARBIDE CORP. CENTRIFICHEM ALP/ALKALINE PHOSPHATASE 02/11/1980
K792413 VOLU SOL MEDICAL INDUSTRIES ELVI ALKALINE PHOSPHATATASE 12/07/1979
K873333 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT ALP 10/02/1987
K013983 WIENER LABORATORIES S.A.I.C. WIENER LAB. ALP 405 01/28/2002


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