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

FDA 510(k) Number Applicant Device Name Decision Date
K881379 AMERICAN BIONETICS, INC. WESBLOT RNP-SM TEST 05/16/1988
K984479 BIO-RAD LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 12/22/1998
K024219 BIO-RAD LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 01/15/2003
K990625 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-SM ELISA 04/28/1999
K841930 DIAGNOSTIC CHEMICALS, LTD. (USA) ENZYMATIC ACETAMINOPHEN ASSAY 06/25/1984
K930141 ELIAS USA, INC. SYNELISA SM ABS/RNP-SM ABS 05/11/1993
K013263 FRED HUTCHINSON CANCER RESEARCH CENTER FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST 07/29/2002
K911848 GENERAL BIOMETRICS, INC. IMMUNOWELL RNP/SM ANTIBODY TEST 05/07/1991
K911851 GENERAL BIOMETRICS, INC. IMMUNOWELL SM ANTIBODY TEST 05/07/1991
K940510 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT 04/20/1994
K954896 HYCOR BIOMEDICAL, INC. HYTEC AUTOIMMUNE KITS (SM) 03/22/1996
K873741 IMMUNOMEDICS, INC. IMMUSTRIP(TM) SM ELISA TEST SYSTEM 11/04/1987
K123593 INOVA DIAGNOSTICS, INC. QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, 04/17/2013
K895996 LIPOGEN, INC. RHEUMELISA ASSAY FOR SM AUTOANTIBODIES 11/06/1989
K880254 LIPOGEN, INC. SM ANTIBODY TEST KIT 04/06/1988
K954830 ORGENTEC ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY 05/08/1996
K132631 PHADIA US INC. EIA SMDP IMMUNOASSAY 08/29/2014
K000312 PHARMACIA & UPJOHN CO. VARELISA SM ANTIBODIES 03/17/2000
K980540 QUEST INTL., INC. SERAQUEST ANTI-SM 06/15/1998
K980811 QUEST INTL., INC. SERAQUEST ANTI-SM/RNP 05/12/1998
K000755 RHIGENE, INC. RHIGENE MESACUP2 TEST- SM 05/09/2000
K905191 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-SM 12/07/1990
K905192 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-SM/RNP 12/07/1990
K042629 SWEDEN DIAGNOSTICS (GERMANY) GMBH VARELISA SM ANTIBODIES, MODEL 18296 12/08/2004
K051066 THERATEST LABORATORIES, INC. THERATEST EL-ANA PROFILES 10/07/2005
K983420 ZEUS SCIENTIFIC, INC. THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO 11/18/1998


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