FDA 510(k) Applications for Medical Device Product Code "LJM"
(Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)

FDA 510(k) Number Applicant Device Name Decision Date
K040953 AESKU, INC AESKULISA ANA HEP-2 06/23/2004
K962052 AMERICAN LABORATORY PRODUCTS CO., LTD. ORGENTEC ABTI-SS-BB(LA) ELISA 11/15/1996
K962053 AMERICAN LABORATORY PRODUCTS CO., LTD. ORGENTEC ANTI-JO-1 ELISA 11/15/1996
K962057 AMERICAN LABORATORY PRODUCTS CO., LTD. ORGENTEC ANTI-RNP/SM ELISA 11/18/1996
K962055 AMERICAN LABORATORY PRODUCTS CO., LTD. ORGENTEC ANTI-SCL 70 ELISA 11/15/1996
K962062 AMERICAN LABORATORY PRODUCTS CO., LTD. ORGENTEC ANTI-SM ELISA 11/18/1996
K962054 AMERICAN LABORATORY PRODUCTS CO., LTD. ORGENTEC ANTI-SS-A(RO) ELISA 11/15/1996
K842532 AMICO LAB, INC. AMIZYME-ANA TEST KIT 09/20/1984
K842533 AMICO LAB, INC. AMIZYME-ANDNA TEST KIT 09/20/1984
K932424 APOTEX SCIENTIFIC, INC. ANA PROFILE I 08/10/1993
K843745 APPLE DIAGNOSTIC PRODUCTS ADP ANA APPLEZYME 10/25/1984
K941509 BIO-RAD RADIAS ANA SCREEN ENZYME IMMUNOASSAY 06/30/1994
K924087 BIO-RAD LABORATORIES, INC. KALESTAD ANA MICROPLATE EIA 11/02/1992
K862969 BIOHYTECH INTERNATIONAL, INC. ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT 10/24/1986
K870456 BIOHYTECH INTERNATIONAL, INC. DNP EIA DIAGNOSTIC KIT 03/17/1987
K870453 BIOHYTECH INTERNATIONAL, INC. DS-DNA EIA DIAGNOSTIC KIT 03/24/1987
K870457 BIOHYTECH INTERNATIONAL, INC. RNP EIA DIAGNOSTIC KIT 03/17/1987
K870455 BIOHYTECH INTERNATIONAL, INC. SM EIA DIAGNOSTIC KIT 03/17/1987
K870452 BIOHYTECH INTERNATIONAL, INC. SS-DNA EIA DIAGNOSTIC KIT 03/17/1987
K940700 CAMBRIDGE LIFE SCIENCES PLC. AUTOZYME SCREEN 06/10/1994
K872839 CAPPEL DIAGNOSTICS, INC. ANTINUCLEAR ANTIBODY TEST 10/20/1987
K983655 COGENT DIAGNOTICS LTD. AUTOSTAT II ANA SCREEN ELISA 01/28/1999
K940253 DAVID A. FUCCILLO, PH.D. HISTONE EIA TEST KIT 05/02/1994
K935415 DAVID A. FUCCILLO, PH.D. RNP EIA TEST KIT 05/02/1994
K935416 DAVID A. FUCCILLO, PH.D. RO EIA TEST KIT 05/02/1994
K935414 DAVID A. FUCCILLO, PH.D. SM EIA TEST KIT 05/02/1994
K902915 DIAMEDIX CORP. ANTI-SCI-70 MICROASSAY 09/06/1990
K894894 DIAMEDIX CORP. ANTI-SM MICROASSAY 08/24/1989
K932206 ELIAS U.S.A., INC. SYNELISA ANA PROFILE 12/03/1993
K940641 ELIAS USA, INC. ELIAS ANA TOTAL 03/25/1994
K964385 ELIAS USA, INC. ELIAS ANA-HEP-2 03/06/1997
K935468 ELIAS USA, INC. SYNELISA ANA TOTAL 03/25/1994
K930209 ELIAS USA, INC. SYNELISA RO ABS / LA ABS 06/11/1993
K963291 ELIAS USA, INC. VARELISA ANA (4) PROFILE 09/30/1996
K951205 ELIAS USA, INC. VARELISA ANA PROFILE 04/17/1995
K951186 ELIAS USA, INC. VARELISA ANA-4 SCREEN 04/17/1995
K944171 ELIAS USA, INC. VARELISA CENTROMERE ANTIBODIES 12/22/1994
K951207 ELIAS USA, INC. VARELISA HISTONE ANTIBODIES 04/17/1995
K944173 ELIAS USA, INC. VARELISA JO-1 ANTIBODIES 12/22/1994
K944168 ELIAS USA, INC. VARELISA LA (SS-B) ANTIBODIES 12/22/1994
K944167 ELIAS USA, INC. VARELISA RNP-SM ANTIBODIES 12/22/1994
K944169 ELIAS USA, INC. VARELISA RO (SS-A) ANTIBODIES 12/22/1994
K944172 ELIAS USA, INC. VARELISA SCL-70 ANTIBODIES 12/22/1994
K944170 ELIAS USA, INC. VARELISA SM ANTIBODIES 12/22/1994
K131185 EUROIMMUN US ANA SCREEN ELISA (IGG) 07/15/2013
K896347 GENERAL BIOMETRICS, INC. IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 12/05/1989
K900072 GENERAL BIOMETRICS, INC. IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 01/24/1990
K131330 GOLD STANDARD DIAGNOSTICS GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT 01/28/2014
K980337 HELIX DIAGNOSTICS, INC. DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM 05/12/1998
K951850 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT 07/18/1995
K951798 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT 07/17/1995
K915272 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) 03/17/1992
K946218 HOGAN & HARTSON MARDX ENA EIA TEST SYSTEM 05/15/1995
K950110 HOGAN & HARTSON MARDX MITOCHONDRIA EIA TEST SYSTEM 05/15/1995
K962450 HYCOR BIOMEDICAL, INC. HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE 11/25/1996
K822346 ICL SCIENTIFIC HISTIMUNE ENZYME-ANA TEST 10/08/1982
K943585 IMMCO DIAGNOSTICS, INC. ANTI-HISTONE ANIBODY TEST 01/20/1995
K041102 IMMCO DIAGNOSTICS, INC. IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA 10/26/2004
K151559 IMMCO DIAGNOSTICS, INC. ImmuLisa Enhanced Centromere Antibody ELISA 03/11/2016
K833148 IMMUNO CONCEPTS, INC. ENZYME ANA TEST SYSTEM 11/21/1983
K992041 IMMUNO CONCEPTS, INC. RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 07/23/1999
K852231 IMMUNO-PRODUCTS INDUSTRIES ANA/LITE-HEP-2 TEST SYSTEM 07/10/1985
K852230 IMMUNO-PRODUCTS INDUSTRIES ANA/LITE-RL TEST SYSTEM 07/10/1985
K123880 INOVA DIAGNOSTICS, INC. QUANTA FLASH CENTROMERE 02/07/2014
K003959 INOVA DIAGNOSTICS, INC. QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA 01/22/2001
K954380 INOVA DIAGNOSTICS, INC. QUANTA LITE SSDNA 02/29/1996
K924248 J.S. MEDICAL ASSOC. ACCUTEX SLE LATEX TEST 11/02/1992
K874195 LIPOGEN, INC. LA ANTIBODY TEST KIT 03/11/1988
K875246 LIPOGEN, INC. LIPOGEN ANA TEST KIT 02/10/1988
K892421 LIPOGEN, INC. MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST 05/09/1989
K895994 LIPOGEN, INC. RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES 10/24/1989
K895995 LIPOGEN, INC. RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES 10/27/1989
K000934 MICRO DETECT, INC. MDI SCL-70 TEST 04/07/2000
K993635 MICRO DETECT, INC. MDI SM/RNP TEST 01/10/2000
K993636 MICRO DETECT, INC. MDI SS-A TEST 01/10/2000
K852840 MODERN DIAGNOSTICS, INC. ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST 08/01/1985
K954829 ORGENTEC ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY 04/18/1996
K954814 ORGENTEC ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY 04/18/1996
K954815 ORGENTEC ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY 04/18/1996
K954832 ORGENTEC ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY 04/18/1996
K030929 ORGENTEC DIAGNOSTIKA GMBH ANA DETECT 05/02/2003
K140493 PHADIA GMBH ELIA SCL-70S IMMUNOASSAY 10/30/2014
K083188 PHADIA US INC. VARELISA RECOMBI ANA SCREEN, MODEL 12 596 03/13/2009
K993109 PHARMACIA & UPJOHN CO. VARELISA RECOMBI ANA PROFILE 11/12/1999
K993108 PHARMACIA & UPJOHN CO. VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 11/12/1999
K040810 PHARMACIA DEUTSCHLAND GMBH VARELISA HISTONE ANTIBODIES, MODEL 16496 05/14/2004
K980810 QUEST INTL., INC. SERAQUEST ANTI-SSA 05/12/1998
K914853 READS MEDICAL PRODUCTS, INC. ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT 01/15/1992
K040200 RHIGENE, INC. MESACUP-2 TEST CENP-B 03/04/2004
K994071 RHIGENE, INC. RHIGENE ANA ELISA TEST SYSTEM 01/18/2000
K022018 RHIGENE, INC. RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 07/05/2002
K952490 ROCHE IMAGE ANALYSIS SYSTEMS IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM 12/15/1995
K920616 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-HISTONE KIT 07/14/1992
K905190 SHIELD DIAGNOSTICS, LTD. DIASTAT ENA PROFILE 12/07/1990
K050625 SWEDEN DIAGNOSTICS (GERMANY) GMBH VARELISA RECOMBI ANA PROFILE, MODEL 18496 04/26/2005
K050967 SWEDEN DIAGNOSTICS (GERMANY) GMBH VARELISA RECOMBI CTD SCREEN, MODEL 13096 06/28/2005
K004019 THE BINDING SITE, LTD. ANA EIA DIAGNOSTIC TEST KIT 02/15/2001
K002559 THERATEST LABORATORIES, INC. EL-ANA PROFILES-2K1 09/12/2000
K040291 THERATEST LABORATORIES, INC. EL-ANA PROFILES: ANTI-CHROMATIN 03/11/2004
K024031 THERATEST LABORATORIES, INC. THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE 02/06/2003
K950716 THERATEST LABORATORIES, INC. THERATEST EL-ANA PROFILES TEST SYSTEM 09/26/1995
K955481 THERATEST LABORATORIES, INC. THERATEST KIT (MODIFICATION) 03/06/1996
K954106 THERATEST LABORATORIES, INC. THERATEST LAB, INC., EL-ANASCR KIT 11/14/1995
K910033 UNITED BIOTECH, INC. UBI MAGIWEL(TM) ANA QUANTITATIVE 01/25/1991
K843904 WHITTAKER BIOPRODUCTS, INC. DNA STAT TEST KIT 11/01/1984
K933267 ZEUS SCIENTIFIC, INC. AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM 12/15/1993
K941409 ZEUS SCIENTIFIC, INC. ENA PROFILE-6 ELISA TEST SYSTEM 06/10/1994
K941014 ZEUS SCIENTIFIC, INC. ENA SCREEN ELISA TEST SYSTEM 06/10/1994
K000880 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE 05/22/2000
K983378 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. 11/18/1998
K000879 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE 05/22/2000


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