FDA 510(k) Applications for Medical Device Product Code "LKJ"
(Antinuclear Antibody, Antigen, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K081104 AESKU.DIAGNOSTICS AESKULISA ANA HEP-2, REF 30-7115US 05/02/2008
K885224 AUTOIMMUNITY DIAGNOSTICS CORP. ANA-5 AUTOANTIBODY PROFILE KIT 04/14/1989
K984473 BIO-RAD LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 12/22/1998
K984464 BIO-RAD LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 12/22/1998
K024223 BIO-RAD LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 01/13/2003
K984475 BIO-RAD LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 12/22/1998
K024226 BIO-RAD LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 01/10/2003
K984470 BIO-RAD LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 12/22/1998
K024218 BIO-RAD LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 01/17/2003
K984478 BIO-RAD LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 12/22/1998
K024232 BIO-RAD LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 01/17/2003
K113610 Bio-Rad Laboratories ANA-SCREEN WITH MDSS 07/09/2012
K041658 BIO-RAD LABORATORIES, INC. BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 12/20/2004
K893896 BIOSTAR MEDICAL PRODUCTS, INC. QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA 07/14/1989
K893897 BIOSTAR MEDICAL PRODUCTS, INC. SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM 06/23/1989
K932679 BIOWHITTAKER MOLECULAR APPLICATIONS, INC. RHEUMELISA II HISTONE ANTIBODY TEST KIT 08/23/1993
K920150 CLARK LABORATORIES, INC. ENCORE SCL-70 03/18/1992
K913342 COGENT DIAGNOTICS LTD. AUTOSTAT(TM) ANTI-DSNA 05/01/1992
K961815 CONSOLIDATED TECHNOLOGIES, INC. QUALITROL ANA CONTROL SERUM SET 09/27/1996
K842484 COOPER BIOMEDICAL, INC. LEAP LE TEST KIT 07/11/1984
K034013 CORGENIX, INC. REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 01/08/2004
K873249 CYTOTECH, INC. ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS 09/22/1987
K021257 DIAGNOSTIC PRODUCTS CORP. ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) 06/03/2002
K914550 DIAGNOSTIC RESOURCES, INC. ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM 02/11/1992
K831463 DIAGNOSTIC TECHNOLOGY, INC. ANA-CHECK 06/08/1983
K993294 DIAMEDIX CORP. DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM 10/25/1999
K921132 ELIAS U.S.A., INC. SYN ELISA DSDNA ANTIBODIES 12/01/1992
K932302 ELIAS USA, INC. SYLNELISA HISTONE ANTIBODIES 08/23/1993
K931255 ELIAS USA, INC. SYNELISA CENP-B ANTIBODIES 09/24/1993
K954723 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY ANA SCREENING TEST KIT 12/15/1995
K954700 HELIX DIAGNOSTICS, INC. ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT 12/15/1995
K894411 HEMAGEN DIAGNOSTICS, INC. SERATEST ENA [SCL-70] KIT 08/02/1989
K954392 HYCOR BIOMEDICAL, INC. HYTEC AUTOIMMUNE KIT (SS-A) 12/26/1995
K954891 HYCOR BIOMEDICAL, INC. HYTEC AUTOIMMUNE KITS (SS-B) 12/26/1995
K883883 IMMCO DIAGNOSTICS, INC. ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) 10/27/1988
K883949 IMMCO DIAGNOSTICS, INC. ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) 10/27/1988
K030775 IMMUNO CONCEPTS, N.A., LTD AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM 05/12/2003
K862313 KALLESTAD LABORATORIES, INC. KALLESTAD SM/RNP TEST REAGENT 08/06/1986
K882740 LIPOGEN, INC. ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY 09/22/1988
K082759 PHADIA US INC. ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY 04/10/2009
K842563 SERAGEN DIAGNOSTICS, INC. SERATEST DNA DETERMINATION 10/25/1984
K932876 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT 11/15/1993
K912291 SHIELD DIAGNOSTICS, LTD. DISTAT ANTI-SCL-70 KIT 07/30/1991
K874115 SIGMA DIAGNOSTICS, INC. NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) 11/04/1987
K914454 THERATEST LABORATORIES, INC. THE THERATEST EL-ANA PROFILES 05/22/1992
K864668 VAL TECH DIAGNOSTICS, INC. "ANA TEST KIT" 03/12/1987
K042416 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA-II TEST SYSTEM 10/08/2004
K021103 ZEUS SCIENTIFIC, INC. MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM 04/24/2002
K011244 ZEUS SCIENTIFIC, INC. ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM 12/10/2001


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact