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 |
| K983655 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANA SCREEN ELISA | 01/28/1999 |
| K964385 | ELIAS USA, INC. | ELIAS ANA-HEP-2 | 03/06/1997 |
| K963291 | ELIAS USA, INC. | VARELISA ANA (4) PROFILE | 09/30/1996 |
| K131185 | EUROIMMUN US | ANA SCREEN ELISA (IGG) | 07/15/2013 |
| 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 |
| K962450 | HYCOR BIOMEDICAL, INC. | HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE | 11/25/1996 |
| K041102 | IMMCO DIAGNOSTICS, INC. | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | 10/26/2004 |
| K151559 | IMMCO DIAGNOSTICS, INC. | ImmuLisa Enhanced Centromere Antibody ELISA | 03/11/2016 |
| K992041 | IMMUNO CONCEPTS, INC. | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | 07/23/1999 |
| 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 |
| 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 |
| 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 |
| K182353 | Phadia AB | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | 11/27/2018 |
| 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 |
| 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 |
| 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 |
| K955481 | THERATEST LABORATORIES, INC. | THERATEST KIT (MODIFICATION) | 03/06/1996 |
| 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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