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 |
| K032469 | AESKU, INC | AESKULISA ANA 8PRO | 12/16/2003 |
| K041753 | AESKU.DIAGNOSTICS | AESKULISA ENA 6 S | 07/14/2004 |
| 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 |
| 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 |
| 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 |
| K112996 | EUROIMMUN US | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | 04/09/2013 |
| K000489 | HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | 04/05/2000 |
| 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 |
| 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 |
| 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 |
| K213403 | Inova Diagnostics, Inc. | Aptiva CTD Essential Reagent | 09/29/2023 |
| 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 |
| K961913 | INOVA DIAGNOSTICS, INC. | QUANTA LITE ENA 6 ELISA | 07/10/1996 |
| K981857 | INOVA DIAGNOSTICS, INC. | QUANTA LITE TPO ELISA | 07/29/1998 |
| 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 |
| 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 |
| K190710 | Phadia AB | EliA SymphonyS Immunoassay | 11/29/2019 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
