FDA 510(k) Applications for Medical Device Product Code "CFJ"
(Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase)

FDA 510(k) Number Applicant Device Name Decision Date
K051108 ABAXIS, INC. PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM 07/08/2005
K841703 ABBOTT LABORATORIES TDX REA LDH 06/08/1984
K881474 ABBOTT LABORATORIES VISION(R) LDH (LACTATE DEHYDROGENASE) 06/01/1988
K850378 ADVANCED BIOMEDICAL METHODS, INC. LDH REAGENT FOR DEMAND ANALYZER 03/01/1985
K131975 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT 10/02/2013
K091544 ALFA WASSERMANN, INC. S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 09/09/2009
K851996 ALPKEM CORP. LD-L REAGENT 05/31/1985
K851997 ALPKEM CORP. LD-P REAGENT 05/30/1985
K840006 AMERICAN MONITOR CORP. KINETIC LDH, A< BLUE 610 METHOD 03/23/1984
K781765 AMERICAN MONITOR CORP. LDH REAGENT SYSTEM 11/22/1978
K900667 AMERICAN RESEARCH PRODUCTS CO. AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 04/19/1990
K852948 AMRESCO, INC. AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI 08/07/1985
K823721 AMRESCO, INC. FLOW-PAC LDH REAGENT SET 01/09/1983
K831353 BECKMAN INSTRUMENTS, INC. ASTRA SYSTEMS ENZYME MODULE 06/08/1983
K832048 BECKMAN INSTRUMENTS, INC. ASTRA SYSTEMS ENZYME MODULE LD-P 07/19/1983
K802572 BECKMAN INSTRUMENTS, INC. BECKMAN LIQUID-STAT LD-L-UV ENZYME 11/12/1980
K780041 BECKMAN INSTRUMENTS, INC. LACTATE DEHYDROGENASE 02/01/1978
K810083 BIO-ANALYTICS LABORATORIES, INC. LDH-L LIQUID ENZYMATIC, KINETIC KIT 01/28/1981
K871781 BIOCHEMICAL TRADE, INC. ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET 06/03/1987
K822492 BIORENT DIAGNOSTIC, INC. OPTIMIZED UV-LDH REAGENT SET 09/17/1982
K905683 BIOTROL, USA, INC. BIOTROL LACTATE DEHYDROGENASE (L-P) 03/11/1991
K790248 BOEHRINGER LABORATORIES NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) 04/04/1979
K820378 BOEHRINGER MANNHEIM CORP. LD-L TRIS SYSTEM PACK TEST 03/08/1982
K780563 BOEHRINGER MANNHEIM CORP. SINGLE VIAL LACTATE 04/18/1978
K781538 BOEHRINGER MANNHEIM CORP. SINGLE VIAL LDH-L TRIS 10/03/1978
K971398 CAROLINA LIQUID CHEMISTRIES CORP. LD-L REAGENT 05/02/1997
K860713 CATACHEM, INC. LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. 04/24/1986
K897164 COULTER ELECTRONICS, INC. COULTER LD (LDH-L) REAGENT 03/09/1990
K915803 DATA MEDICAL ASSOCIATES, INC. DMA LD KINETIC PROCEDURE 03/18/1992
K861662 DATA MEDICAL ASSOCIATES, INC. LACTATE DEHYDROGENASE (LD) PROCEDURE 05/29/1986
K863255 DATA MEDICAL ASSOCIATES, INC. LACTATE DEHYDROGENASE(LD) PROCEDURE 10/03/1986
K964912 DERMA MEDIA LAB., INC. LACTATE DEHYDROGENASE 01/09/1997
K974859 DIAGNOSTIC CHEMICALS LTD. LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 01/22/1998
K842507 DIAGNOSTIC CHEMICALS, LTD. (USA) LACTATE DEHYDROGENASE ASSAY KIT 07/20/1984
K875206 DIAGNOSTIC CHEMICALS, LTD. (USA) LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 02/02/1988
K842244 DIAGNOSTIC CHEMICALS, LTD. (USA) LACTATE DENYDRO GENASE ASSAY KIT 07/18/1984
K800691 DIAGNOSTIC SOLUTIONS, INC. REAGENT FOR DETERM. LACTATE/DEHYDROGENAS 05/28/1980
K883206 ELECTRO-NUCLEONICS, INC. LACTATE DEHYDROGENASE LDH 09/09/1988
K914262 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART LDH,#5A31 10/11/1991
K863545 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 09/25/1986
K863477 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 09/26/1986
K935175 EM DIAGNOSTIC SYSTEMS, INC. LACTATE DEHYDROGENASE (LD) 12/16/1993
K924703 EM DIAGNOSTIC SYSTEMS, INC. LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 02/05/1993
K894482 EM DIAGNOSTIC SYSTEMS, INC. LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 09/07/1989
K884548 EM DIAGNOSTIC SYSTEMS, INC. LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 11/10/1988
K910640 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 04/12/1991
K843269 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE LDH, 67210 09/13/1984
K854585 EM DIAGNOSTIC SYSTEMS, INC. ULTRAZYME PLUS & SYSTEMATE LDH 12/05/1985
K821466 EMD CHEMICALS INC. ULTRAZYME PLUS LDH, #64950,65038&65039 06/01/1982
K790020 FISHER SCIENTIFIC CO., LLC. SERUM, LACTIC DEHYDROGENASE 02/08/1979
K771836 GAMMA ENTERPRISES, INC. LACTATE DEHYDROGENASE 11/22/1977
K790771 GILFORD DIAGNOSTICS LD-P REAGENT (LDH P-L REAGENT) 05/15/1979
K781775 GILFORD DIAGNOSTICS LDH 11/22/1978
K800120 GILFORD DIAGNOSTICS LDH (L-P) REAGENT 02/13/1980
K772028 HARLECO GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH 11/15/1977
K812590 HARLECO ULTRA ZYME PLUS LDH #64950, 65038 & 39 09/24/1981
K780101 HARLECO ULTRAZYME PLUS LDH 02/14/1978
K770818 HARLECO ULTRAZYME PLUS, LDH 07/11/1977
K770613 HARLECO DIAGNOSTICS LDH ULTRAZYME PLUS 06/17/1977
K821878 HARLECO DIAGNOSTICS ULTRAZYME PLUS LDH 07/14/1982
K861419 HI CHEM, INC. HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE 04/28/1986
K862027 HI CHEM, INC. LDP REAGENT CARTRIDGE (NO. 88216) 06/13/1986
K946022 HICHEM DIAGNOSTICS HICHEM LDH/L REAGENT KIT 02/23/1995
K792658 HOFFMANN-LA ROCHE, INC. COBAS-BLO REAGENTS (LACTATE DEHYDRO 01/17/1980
K770313 ICN PHARMACEUTICALS, INC. REAGENT LDH-L, ENZYME 04/05/1977
K771465 INSTRUMENTATION LABORATORY CO. MULTISTAT III LACTIC DEHYDROGENASE 09/02/1977
K863068 J. D. ASSOC. LDH S.C.E. 12/10/1986
K760410 J.T. BAKER CHEMICAL CO. AMP BUFFER 10/29/1976
K761343 J.T. BAKER CHEMICAL CO. DYNAZYME-II TM LDH-L 340 KIT 01/05/1977
K760412 J.T. BAKER CHEMICAL CO. LDH SUBSTRATE 11/02/1976
K760411 J.T. BAKER CHEMICAL CO. NAD (SPOONPAK CONTAINER) 10/29/1976
K862306 KING DIAGNOSTICS, INC. KING DIAGNOSTICS LDH TEST 08/19/1986
K781128 MACOMB CHEMICAL CO. LDH (UV KINETIC) 08/10/1978
K781724 MEDICAL ANALYSIS SYSTEMS, INC. NAD REDUCTION METHOD, LACTATE PYRIVATE 11/03/1978
K952747 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. LACTATE DEHYDROGENASE REAGENT SYSTEM 08/07/1995
K841058 MEDICAL SPECIALTIES, INC. LDH-UV REAGENT SET 05/01/1984
K803019 MILES LABORATORIES, INC. SERALYZER LDH REAGENT STRIPS, CALIBR 12/22/1980
K870752 MILES LABORATORIES, INC. SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS 04/14/1987
K923412 OLYMPUS CORP. OLYMPUS LACTATE DEHYDROGENASE REAGENT 09/18/1992
K924965 OLYMPUS CORP. OLYMPUS LACTATE DEHYDROGENASE REAGENT 11/16/1992
K821201 OMEGA MEDICAL ELECTRONICS LDH-UV REAGENT SET 07/20/1982
K961431 POINTE SCIENTIFIC, INC. LACTATE DEHYDROGENASE REAGENT SET 06/03/1996
K813496 POINTE SCIENTIFIC, INC. LDH-L 12/31/1981
K973589 POINTE SCIENTIFIC, INC. LIQUID LDH-L REAGENT SET 10/08/1997
K760345 PRINCETON BIOMEDIX TEST, LACTATE DEHYDROGENASE 10/27/1976
K942964 PRISMA SYSTEMS LACTATE DEHYDROGENASE QVET 12/29/1994
K970684 RANDOX LABORATORIES, LTD. LACTATE DEHYDROGENASE (LD) 05/07/1997
K822312 REAGENTS APPLICATIONS, INC. RAICHEM LDH-L REAGENT 08/27/1982
K831419 REAGENTS APPLICATIONS, INC. RAICHEM LDH-P REAGENT W/SEPARATE START- 06/16/1983
K896241 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY LDH REAGENT 02/16/1990
K900121 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR LDH 03/30/1990
K770267 SCLAVO, INC. LDH-L TEST 02/23/1977
K872030 SCLAVO, INC. UNI-FAST LACTATE DEHYDROGENASE (LDH-L) 07/07/1987
K860029 SIGMA CHEMICAL CO. LDH (OPTIMIZED) REAGENT 02/06/1986
K841917 SIGMA DIAGNOSTICS, INC. SIGMS PROCED. 228 UV LACTATE DEHYDRO 06/14/1984
K760476 SIMMLER & SON, INC. REAGENT, LACTATE DEHYDROGENASE 11/01/1976
K872010 SIMMLER, INC. MULTICHEM LDH-L REAGENT 06/11/1987
K791085 SMITH KLINE DIAGNOSTICS, INC. PLUS CHEM, DETERMINATION OF LD (LDH-P) 07/17/1979
K791081 SMITH KLINE DIAGNOSTICS, INC. SPIN CHEM REAGENT, DETERMINATION OF LDH- 07/17/1979
K812472 SMITH KLINE DIAGNOSTICS, INC. SPIN-CHEM LD-L REAGENT 09/14/1981
K831415 STERLING BIOCHEMICAL, INC. LACTIC DEHYDROGENASE REAGENT SET 06/16/1983
K862255 STERLING DIAGNOSTICS, INC. LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) 07/29/1986
K903773 SYNERMED, INC. SYNERMED LDH REAGENT KIT 10/12/1990
K921025 SYNERMED, INC. SYNERMED LDHH-L REAGENT KIT 03/23/1992
K874848 TECH-CO, INC. LACTATE DEHYDROGENASE LDH-L 12/18/1987
K880842 TECH-NEAL SCIENTIFIC, INC. LDH-L REAGENT SET 04/05/1988
K855157 TECHNOSTICS INTL. LACTIC DEHYDROGENASE (VV) REAGENT SET 01/21/1986
K855159 TECHNOSTICS INTL. LACTIC DEHYDROGENASE REAGENT SET 01/14/1986
K860728 TRACE SCIENTIFIC LTD. L D H-L (LACTIC DEHYDROGENASE) REAGENT 04/07/1986
K860729 TRACE SCIENTIFIC LTD. LDH-P (LACTIC DEHYDROGENASE) REAGENT 04/07/1986
K870401 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT LDH 03/06/1987


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