FDA 510(k) Applications for Medical Device Product Code "LLL"
(Extractable Antinuclear Antibody, Antigen And Control)

FDA 510(k) Number Applicant Device Name Decision Date
K924951 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DOXA COMBI-4 05/19/1993
K924952 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DOXA COMBI-6 05/19/1993
K924950 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DOXA JO-1 05/19/1993
K924949 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DOXA SCL-70 05/19/1993
K924947 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DOXA SM 05/19/1993
K924948 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DOXA SM/RNP 05/19/1993
K924946 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DOXA SSB 05/19/1993
K924945 ADVANCED BIOLOGICAL PRODUCTS, INC. ELISA-DPXA SSA KIT 05/19/1993
K032469 AESKU, INC AESKULISA ANA 8PRO 12/16/2003
K041753 AESKU.DIAGNOSTICS AESKULISA ENA 6 S 07/14/2004
K810592 ALPHA ANTIGENS, INC. NUCLEAR ANTIGENS 10/23/1981
K871994 BEHRING DIAGNOSTICS, INC. ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) 08/12/1987
K843978 BEHRING DIAGNOSTICS, INC. ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY 12/18/1984
K984462 BIO-RAD LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 12/22/1998
K043067 BIOARRAY SOLUTIONS LTD ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 05/31/2005
K053653 BIOMEDICAL DIAGNOSTICS (BMD) SA FIDIS CONNECTIVE 10, MODEL MX006 03/13/2006
K050286 BIOMEDICAL DIAGNOSTICS (BMD) SA FIDIS CONNECTIVE 8 10/03/2005
K102607 BIOMEDICAL DIAGNOSTICS (BMD) SA FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS 12/03/2010
K901230 BIOSEARCH MEDICAL PRODUCTS, INC. REAADS ANTI-SM TEST KIT 03/23/1990
K901924 BIOSEARCH MEDICAL PRODUCTS, INC. READS(R) ANTI-ENA (SM/RNP) TEST KIT 05/09/1990
K930757 BIOWHITTAKER MOLECULAR APPLICATIONS, INC. RHEUMELISA II JO-1 ANTIBODY TEST KIT 03/26/1993
K930130 BIOWHITTAKER MOLECULAR APPLICATIONS, INC. RHEUMELISA II SCL-70 ANTIBODY TEST KIT 03/23/1993
K831036 CALBIOCHEM-BEHRING CORP. ENA TEST KIT SM & RNP AUTO ANTIBODY 04/27/1983
K922241 CAMBRIDGE LIFE SCIENCES PLC. AUTOZYME 11/30/1992
K931543 CLARK LABORATORIES, INC. ENCORE ENA COMBINED EIA 09/08/1993
K921572 CLARK LABORATORIES, INC. ENCORE SM 12/01/1992
K921870 CLARK LABORATORIES, INC. ENCORE SM/RNP 12/01/1992
K922157 CLARK LABORATORIES, INC. ENCORE SS-A 10/13/1992
K922340 CLARK LABORATORIES, INC. ENCORE SS-B 10/16/1992
K990798 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-JO-1 ELISA 04/28/1999
K990797 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-SCL-70 ELISA 04/28/1999
K990627 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-SS-A/RO ELISA 04/28/1999
K990626 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-SS-B/LA ELISA 04/28/1999
K983921 COGENT DIAGNOTICS LTD. AUTOSTAT II ENA SCREEN ELISA 12/28/1998
K003057 COGENT DIAGNOTICS LTD. AUTOSTAT II ENA-4 PROFILE ELISA 10/13/2000
K003054 COGENT DIAGNOTICS LTD. AUTOSTAT II ENA-6 PROFILE ELISA 10/13/2000
K935413 DAVID A. FUCCILLO, PH.D. ENA EIA TEST KIT 06/02/1994
K935417 DAVID A. FUCCILLO, PH.D. JO-1 EIA TEST KIT 05/05/1994
K935419 DAVID A. FUCCILLO, PH.D. LA EIA TEST KIT 05/05/1994
K935418 DAVID A. FUCCILLO, PH.D. SCL-70 EIA TEST KIT 05/05/1994
K911679 DIAMEDIX CORP. ANTI-JO-1 MICROASSAY 09/23/1991
K901073 DIAMEDIX CORP. ANTI-RNP MICROASSAY 03/19/1990
K900241 DIAMEDIX CORP. ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY 02/02/1990
K980759 DIAMEDIX CORP. DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM 04/23/1998
K970228 DIAMEDIX CORP. IS-ANTI-JO-1 TEST SYSTEM 04/08/1997
K970239 DIAMEDIX CORP. IS-ANTI-SCL-70 TEST SYSTEM (720-280) 04/08/1997
K970220 DIAMEDIX CORP. IS-ANTI-SM TEST SYSTEM 04/08/1997
K970238 DIAMEDIX CORP. IS-ANTI-SM/RNP (720-270) 04/08/1997
K970218 DIAMEDIX CORP. IS-ANTI-SSA TEST SYSTEM 04/08/1997
K970237 DIAMEDIX CORP. IS-ANTI-SSB TEST SYSTEM (720-260) 04/08/1997
K940622 ELIAS USA, INC. ELIAS ENA SCREEN (MICROTITER PLATE) 05/11/1994
K940229 ELIAS USA, INC. SYN ENA SCREEN (PIN PLATE) 05/11/1994
K930281 ELIAS USA, INC. SYNELISA JO-1 ANTIBODIES 04/06/1993
K930417 ELIAS USA, INC. SYNELISA SCL-70 ANTIBODIES 04/06/1993
K112996 EUROIMMUN US EUROIMMUN ANTI-ENA POOL ELISA (IGG) 04/09/2013
K903047 GENERAL BIOMETRICS, INC. IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 08/09/1990
K902938 GENERAL BIOMETRICS, INC. IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 08/09/1990
K924843 GENERAL BIOMETRICS, INC. IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL 12/01/1992
K913041 HELIX DIAGNOSTICS, INC. ANTI-DSDNA ANTIBODY TEST 11/05/1991
K932419 HELIX DIAGNOSTICS, INC. ANTI-SS-B/LA ANTIBODY TEST 08/05/1993
K932850 HELIX DIAGNOSTICS, INC. ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN 09/24/1993
K000489 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST 04/05/2000
K931495 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT 07/16/1993
K952253 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT 08/24/1995
K915234 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) 12/20/1991
K946124 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA JO-1 KIT (EIA METHOD) 02/22/1995
K915282 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SCL-70 KIT (EIA METHOD) 02/12/1992
K946122 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SCL-70 KIT (EIA METHOD) 02/22/1995
K952077 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) 06/05/1995
K935828 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) 04/20/1994
K910232 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SCREENING KIT 03/06/1991
K915058 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SCREENING KIT (EIA METHOD) 12/20/1991
K952076 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SCREENING KIT (EIA METHOD) 06/05/1995
K946123 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SM KIT (EIA METHOD) 02/22/1995
K950414 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SM/RMP KIT (EIA METHOD) 03/29/1995
K946121 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SS-A KIT (EIA METHOD) 02/22/1995
K946120 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA SS-B KIT (EIA METHOD) 02/22/1995
K915420 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA [JO-1] KIT (EIA METHOD) 04/07/1992
K862700 HEMAGEN DIAGNOSTICS, INC. SERATEST ENA [SS-B] KIT 08/19/1986
K900617 HEMAGEN DIAGNOSTICS, INC. SERATEST ENA [SSA] KIT 02/23/1990
K962728 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY 03/07/1997
K962731 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY 03/07/1997
K962727 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY 03/07/1997
K962720 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY 03/07/1997
K962722 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY 03/07/1997
K962719 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY 03/07/1997
K962578 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY 03/07/1997
K954895 HYCOR BIOMEDICAL, INC. HYTEC AUTOIMMUNE KIT (JO-1) 03/20/1996
K954894 HYCOR BIOMEDICAL, INC. HYTEC AUTOIMMUNE KITS (SCL-70) 03/20/1996
K954890 HYCOR BIOMEDICAL, INC. HYTEC AUTOMMUNE KIT (ENA) 12/26/1995
K920384 IMMCO DIAGNOSTICS, INC. ANIT-ENA ANTIBODY TEST [SS-B (LA)] 03/30/1992
K920385 IMMCO DIAGNOSTICS, INC. ANTI-ENA ANTIBODY TEST (SM) 03/30/1992
K920386 IMMCO DIAGNOSTICS, INC. ANTI-ENA ANTIBODY TEST KIT 03/30/1992
K920383 IMMCO DIAGNOSTICS, INC. ANTI-ENA ANTIBODY TEST [SS-A (RO)] 03/30/1992
K903314 IMMCO DIAGNOSTICS, INC. ANTI-SCI-70 ANTIBODY TEST 08/14/1990
K895339 IMMCO DIAGNOSTICS, INC. ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST 10/04/1989
K142781 IMMCO DIAGNOSTICS, INC. ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA 03/31/2015
K113143 IMMCO DIAGNOSTICS, INC. IMMULISA SCI-70 ANTIBODY ELISA 12/02/2011
K935129 IMMUNO CONCEPTS, INC. RELISA ENA ANTIBODY SCREENING TEST SYSTEM 01/31/1994
K963275 IMMUNO CONCEPTS, INC. RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM 09/13/1996
K955605 IMMUNO CONCEPTS, INC. RELISA JO-1 ANTIBODY TEST SYSTEM 04/19/1996
K955604 IMMUNO CONCEPTS, INC. RELISA SM/RNP ANTIBODY TEST SYSTEM 04/19/1996
K955602 IMMUNO CONCEPTS, INC. RELSIA SCL-70 ANTIBODY TEST SYSTEM 04/19/1996
K955603 IMMUNO CONCEPTS, INC. RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM 04/19/1996
K860428 IMMUNO CONCEPTS, INC. SM-RNP AUTOANTIBODY TEST SYSTEM 05/15/1986
K860644 IMMUNO CONCEPTS, INC. SS-A/SS-B AUTOANTIBODY TEST SYSTEM 03/28/1986
K880897 INOVA DIAGNOSTICS, INC. NOVA GEL (TM) SCL-70 04/21/1988
K896462 INOVA DIAGNOSTICS, INC. NOVA GEL(TM) "T" JO-1 11/20/1989
K896461 INOVA DIAGNOSTICS, INC. NOVA GEL(TM) "T" SCL-70 11/20/1989
K896459 INOVA DIAGNOSTICS, INC. NOVA GEL(TM) "T" SM/RNP 11/20/1989
K896460 INOVA DIAGNOSTICS, INC. NOVA GEL(TM) "T" SS-A/SS-B 11/20/1989
K892897 INOVA DIAGNOSTICS, INC. NOVA GEL(TM) JO-1 05/17/1989
K881181 INOVA DIAGNOSTICS, INC. NOVA GEL(TM) SM/RNP 04/06/1988
K880896 INOVA DIAGNOSTICS, INC. NOVA GEL(TM) SS-A/SS-B 03/25/1988
K880736 INOVA DIAGNOSTICS, INC. NOVA LITE(TM) ANA 03/25/1988
K881339 INOVA DIAGNOSTICS, INC. NOVA LITE(TM) ANA PLUS 04/21/1988
K881340 INOVA DIAGNOSTICS, INC. NOVA LITE(TM) AUTOANTIBODY CONTROLS 06/08/1988
K881341 INOVA DIAGNOSTICS, INC. NOVA LITE(TM) SA 09/22/1988
K122923 INOVA DIAGNOSTICS, INC. QUANTA FLASH ENA7 05/07/2013
K180975 Inova Diagnostics, Inc. QUANTA Flash HMGCR Reagents 06/25/2018
K151429 INOVA DIAGNOSTICS, INC. QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols 02/12/2016
K141328 INOVA DIAGNOSTICS, INC. QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS 02/12/2015
K152635 INOVA DIAGNOSTICS, INC. QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls 06/01/2016
K141210 INOVA DIAGNOSTICS, INC. QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS 01/29/2015
K991657 INOVA DIAGNOSTICS, INC. QUANTA LITE ANA ELISA 06/17/1999
K982603 INOVA DIAGNOSTICS, INC. QUANTA LITE CHROMATIN ELISA 10/07/1998
K943076 INOVA DIAGNOSTICS, INC. QUANTA LITE ENA 5 ELISA KIT 10/25/1994
K961913 INOVA DIAGNOSTICS, INC. QUANTA LITE ENA 6 ELISA 07/10/1996
K922829 INOVA DIAGNOSTICS, INC. QUANTA LITE ENA ELISA 09/18/1992
K922833 INOVA DIAGNOSTICS, INC. QUANTA LITE RNP ELISA 09/18/1992
K922831 INOVA DIAGNOSTICS, INC. QUANTA LITE SM ELISA 09/18/1992
K922830 INOVA DIAGNOSTICS, INC. QUANTA LITE SS-A ELISA 09/18/1992
K922832 INOVA DIAGNOSTICS, INC. QUANTA LITE SS-B ELISA 09/18/1992
K903898 INOVA DIAGNOSTICS, INC. QUANTA LITE TM DSDNA 09/05/1990
K981857 INOVA DIAGNOSTICS, INC. QUANTA LITE TPO ELISA 07/29/1998
K934053 INOVA DIAGNOSTICS, INC. QUANTA LITE(TM) HISTONE ELISA 12/21/1993
K926562 INOVA DIAGNOSTICS, INC. QUANTA LITE(TM) JO-1 ELISA KIT 03/04/1993
K924898 INOVA DIAGNOSTICS, INC. QUANTA LITE(TM) SCL-70 ELISA 12/15/1992
K011140 INOVA DIAGNOSTICS, INC. QUANTA PLEX ENA PROFILE 4 07/27/2001
K030681 INOVA DIAGNOSTICS, INC. QUANTA PLEX ENA PROFILE 5 04/24/2003
K031450 INOVA DIAGNOSTICS, INC. QUANTA PLEX ENA PROFILE 6 06/25/2003
K040160 INOVA DIAGNOSTICS, INC. QUANTA PLEX SLE PROFILE 8 03/08/2004
K862710 KALLESTAD LABORATORIES, INC. KALLESTAD SSA/SSB ENA TEST REAGENTS 07/29/1986
K964787 MARDX DIAGNOSTICS, INC. MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM 04/08/1997
K994029 MICRO DETECT, INC. MDI SM TEST 01/11/2000
K993971 MICRO DETECT, INC. MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM 01/11/2000
K955134 ORGENTEC ORGENTEC ENASCREEN ELISA ASSAY 03/20/1996
K955133 ORGENTEC ORGENTEC ENASCREEN PIN IMMUNO ASSAY 03/20/1996
K072149 PHADIA US INC. ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 01/15/2008
K980639 QUEST INTL., INC. SERAQUEST ANTI-SSB 06/15/1998
K843423 RESEARCH MEDICAL, INC. PHYSIO GAS ANALYZER 02/26/1985
K033528 RHIGENE, INC. MESACUP-2 TEST JO-1, MODEL 10756 12/22/2003
K000750 RHIGENE, INC. RHIGENE MESACUP2 TEST- SCL-70 05/09/2000
K000749 RHIGENE, INC. RHIGENE MESACUP2 TEST- SSA 05/09/2000
K000751 RHIGENE, INC. RHIGENE MESACUP2 TEST- SSB 05/09/2000
K844743 SERAGEN DIAGNOSTICS, INC. SERATEST ENA(RNP/SM) DETERMINATION 02/04/1985
K932877 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-CENTROMERE KIT 10/15/1993
K944505 SHIELD DIAGNOSTICS, LTD. DIASTAT ENA SINGLE WELL SCREEN KIT 11/21/1994
K943291 SIGMA DIAGNOSTICS, INC. ANTI DS-DNA 12/02/1994
K925118 THE BINDING SITE, LTD. EN TYPING CIE KIT FOR DIAGNOSTIC USE 02/02/1993
K010147 THE BINDING SITE, LTD. ENA EIA KIT 03/01/2001
K010146 THE BINDING SITE, LTD. ENA EIA KIT RANGE 03/01/2001
K010148 THE BINDING SITE, LTD. ENA SCREEN EIA KIT 02/23/2001
K924262 THE BINDING SITE, LTD. ENA SCREENING CIE KIT FOR DIAGNOSTIC USE 12/29/1992
K982150 THERATEST LABORATORIES, INC. EL-ANA PROFILES: EL-ENA/4 08/13/1998
K982622 THERATEST LABORATORIES, INC. EL-ANA PROFILES: EL-ENA/5 08/13/1998
K993839 TRINITY BIOTECH USA ENA PROFILE ELISA TEST SYSTEM 01/12/2000
K883232 VAL TECH DIAGNOSTICS, INC. HISTONE REACTIVE ANA 09/07/1988
K873708 WHITTAKER BIOPRODUCTS, INC. FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES 11/25/1987
K940362 ZEUS SCIENTIFIC, INC. ANA SCREEN ELISA TEST SYSTEM 07/28/1994
K840221 ZEUS SCIENTIFIC, INC. EXTRACTABLE NUCLEAR ANTIGEN ASSAY 05/22/1984
K983464 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE 11/18/1998
K983423 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE 11/18/1998
K983426 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC 11/18/1998
K983376 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S 11/18/1998
K983425 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET 11/18/1998


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