FDA 510(k) Applications for Medical Device Product Code "KLS"
(Enzyme Immunoassay, Theophylline)

FDA 510(k) Number Applicant Device Name Decision Date
K812003 ABBOTT LABORATORIES A-GENT THEOPHYLLINE 07/27/1981
K926245 ABBOTT LABORATORIES ABBOTT VISION THEOPHYLLINE IIA 05/06/1993
K935373 ABBOTT LABORATORIES AXSYM THEOPHYLLINE 06/21/1994
K833683 ABBOTT LABORATORIES CHEM KIT THEOPHYLLINE DIAG. KIT 12/27/1983
K853834 ABBOTT LABORATORIES VISION THEOPHYLLINE 10/15/1985
K860464 ABBOTT LABORATORIES VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM 06/17/1986
K896927 ABBOTT LABORATORIES VISION THEOPHYLLINE II 01/18/1990
K803094 ACCRA LABORATORIES, INC. COPPER SULFATE SOLUTION SP. GR.1.053 03/06/1981
K834244 ALLERGENETICS THEOFAST TEST KIT FOR QUANTITATIVE THEO 01/24/1984
K853858 ALLIED INSTRUMENTATION LABORATORY IL TEST THEOPHYLLINE ASSAY 10/15/1985
K832965 AMERICAN DADE STRATUS THEOPHYLLINE ASSAY 12/30/1983
K873596 BAKER INSTRUCTIONS CORP. BAKER TDM THEOPHYLLINE ASSAY 10/20/1987
K932685 BAXTER DIAGNOSTICS, INC. PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS 09/24/1993
K013272 BAYER CORP. ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY 10/25/2001
K844170 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM 12/11/1984
K810578 BECKMAN INSTRUMENTS, INC. BECKMAN THEOPHYLLINE REAGENT TEST KIT 03/13/1981
K850856 BECKMAN INSTRUMENTS, INC. ICS THEOPHYLLINE REAGENTS 03/29/1985
K855227 BIOCLINICAL SYSTEMS, INC. MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL 04/11/1986
K933258 BIOMERIEUX VITEK, INC. VIDAS THEOPHYLLINE(THEO) 08/16/1993
K900373 BIOTRACK, INC. BIOTRACK THEOPHYLLINE TEST CARTRIDGE 05/30/1990
K961462 BOEHRINGER MANNHEIM CORP. CEDIA THEOPHYLLINE ASSAY 06/27/1996
K972495 CHEMTRAK, INC. ACCUMETER THEOPHYLLINE TEST 10/10/1997
K772017 CLINICAL ASSAYS, INC. IN VITRO THEOPHYLLINE RIA TEST 03/27/1978
K854183 CLINICAL DATA, INC. IN VITRO TEST DETERMINATION OF THEOPHYLLINE 12/19/1985
K870736 COULTER ELECTRONICS, INC. DART THEOPHYLLINE REAGENT SYSTEM 04/14/1987
K042407 DADE BEHRING, INC. EMIT CAFFEINE ASSAY 10/28/2004
K901510 DIAGNOSTIC CHEMICALS, LTD. (USA) ENZYMATIC THEOPHYLLINE REAGENT, #500-82 06/12/1990
K890002 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT (TM) THEOPHYLLINE 01/23/1989
K954569 DIAGNOSTIC PRODUCTS CORP. IMMULITE THEOPHYLLINE 11/13/1995
K952596 DIAGNOSTIC REAGENTS, INC. THEOPHYLLINE ENZYME IMMUNOASSAY 08/11/1995
K841656 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT THEOPHYLLINE ASSAY KIT 05/22/1984
K862955 E.I. DUPONT DE NEMOURS & CO., INC. METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM 09/25/1986
K831934 E.I. DUPONT DE NEMOURS & CO., INC. THEOPHYLLINE TEST PACK ACA 09/12/1983
K861367 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO) 05/29/1986
K821544 ELECTRO-NUCLEONICS LABORATORIES, INC. DETECTION OF THEOPHYLLINE 06/10/1982
K853372 ELECTRO-NUCLEONICS LABORATORIES, INC. GEMSTAR IPA THEOPHYLLINE TEST KIT 09/04/1985
K862350 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 07/07/1986
K864041 EM DIAGNOSTIC SYSTEMS, INC. EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 11/25/1986
K911060 IMMUNOMATRIX IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM 05/08/1991
K802066 IMMUNOTECH CORP. ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY 10/23/1980
K881257 IMMUNOTECH CORP. EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT 05/27/1988
K943979 INSTRUMENTATION LABORATORY CO. IL TEST THEOPHYLLINE 01/18/1995
K910697 INSTRUMENTATION LABORATORY CO. IL THEOPHYLLINE ASSAY SYSTEM 04/03/1991
K801642 INTL. DIAGNOSTIC TECHNOLOGY FIAX TEST KIT FOR THEOPHYLLINE QUANT. 08/27/1980
K821154 JAY RAU, TECHNICAL SUPPPRT KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME 05/13/1982
K900009 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET 03/29/1990
K884358 MICROGENICS CORP. CEDIA THEOPHYLLINE ASSAY 02/07/1989
K800646 MILES LABORATORIES, INC. AMES TDA THEOPHYL-LINE TEST 04/10/1980
K832825 MILES LABORATORIES, INC. SERALYZER THEOPHYLLINE REAGENT STRIPS 03/19/1984
K042520 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III 11/30/2004
K885044 PB DIAGNOSTIC SYSTEMS, INC. BEHRING POLAROID OPUS THEOPHYLLINE 12/29/1988
K011771 RANDOX LABORATORIES, LTD. RANDOX THEOPHYLLINE 01/17/2002
K020740 ROCHE DIAGNOSTICS CORP. ROCHE ONLINE THEOPHYLLINE 04/16/2002
K973583 SCHIAPPARELLI BIOSYSTEMS, INC. ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS 11/12/1997
K870952 SIGMA DIAGNOSTICS, INC. THEOPHYLLINE FPIA REAGENT SET 03/31/1987
K993029 SYVA CO. ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 01/27/2000
K885253 SYVA CO. ACCULEVEL ONE-STEP THEOPHYLLINE TEST 03/31/1989
K844642 SYVA CO. ACCULEVEL THEOPHYLLINE TEST 03/19/1985
K851741 SYVA CO. ACCULEVEL THEOPHYLLINE TEST(MODIFICATION) 06/06/1985
K801476 SYVA CO. APPLICATION OF EMIT THEOPHYLLINE ASSAY 07/08/1980
K832034 SYVA CO. EMIT AAD THEOPHYLLINE ASSAY 08/01/1983
K853872 SYVA CO. EMIT CAFFEINE ASSAY 06/13/1986
K874578 SYVA CO. EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY 11/24/1987
K831272 SYVA CO. EMIT QST THEOPHYLLINE ASSAY 05/27/1983
K790256 SYVA CO. EMIT THEOPHYLLINE ASSAY 03/02/1979
K913123 SYVA CO. EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS 09/19/1991
K011166 SYVA CO., DADE BEHRING, INC. MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 05/10/2001
K902243 TECHNICON INSTRUMENTS CORP. TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES 07/05/1990
K852573 TECHNICON INSTRUMENTS CORP. TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE 07/12/1985
K884002 THE DU PONT CO. ANALYST THEOPHYLLINE ROTOR 10/31/1988
K833989 VXR, INC. VENTREZYME THEOPHYLLINE IMMUNOASSAY 01/30/1984


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