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 |