FDA 510(k) Applications for Medical Device Product Code "LKO"
(Anti-Rnp Antibody, Antigen And Control)

FDA 510(k) Number Applicant Device Name Decision Date
K984476 BIO-RAD LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 12/22/1998
K071210 BIOMEDICAL DIAGNOSTICS (BMD) SA MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 12/19/2007
K990624 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-SM/RNP ELISA 04/28/1999
K930142 ELIAS USA, INC. SYNELISA U1-SNRNP (68KDA)-ANTIBODIES 05/11/1993
K123261 EUROIMMUN US EUROIMMUN ANTI-NRNP/SM ELISA (IGG) 06/12/2013
K140224 EUROIMMUN US EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) 12/09/2014
K911849 GENERAL BIOMETRICS, INC. IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST 05/07/1991
K911850 GENERAL BIOMETRICS, INC. IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST 05/07/1991
K940588 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT 04/20/1994
K954897 HYCOR BIOMEDICAL, INC. HYTEC AUTOIMMUNE KITS (RNP) 03/22/1996
K895338 IMMCO DIAGNOSTICS, INC. ANTI-RNP AND ANTI-SM ANTIBODY TEST 10/17/1989
K895997 LIPOGEN, INC. RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES 11/06/1989
K874152 LIPOGEN, INC. RNP ANTIBODY TEST KIT 03/11/1988
K831292 MELOY LABORATORIES, INC. ANTI-ENA TEST 07/18/1983
K954831 ORGENTEC ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY 05/08/1996
K083117 PHADIA US INC. ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 05/28/2009
K993589 PHARMACIA & UPJOHN CO. VARELISA RNP ANTIBODIES 11/26/1999
K022017 RHIGENE, INC. RHIGENE MESACUP-2 TEST RNP, MODEL M7741 08/14/2002
K000752 RHIGENE, INC. RHIGENE MESACUP2 TEST- RNP 05/09/2000
K905193 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-LA (SS-B) 12/13/1990
K905194 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-RO (SS-A) 12/13/1990
K983465 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE 11/18/1998


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