Panels › Immunology › Product code LKJ · Class 2
Antinuclear Antibody, Antigen, Control
Regulation 866.5100
0510(k)s in 12 months (50 all time)
0recalls in 12 months (13 all time)
12recalls that name a 510(k)
Top companies in LKJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 2022 | K210902 | EliA Ro52, EliA Ro60 Phadia AB, SE | LKJ |
| Jul 9, 2012 | K113610 | ANA-SCREEN WITH MDSS Bio-Rad Laboratories | LKJ |
| Apr 10, 2009 | K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY Phadia US, Inc. | LKJ |
| May 2, 2008 | K081104 | AESKULISA ANA HEP-2, REF 30-7115US Aesku Diagnostics, DE | LKJ |
| Dec 20, 2004 | K041658 | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 Bio-Rad Laboratories, Inc. | LKJ |
| Oct 8, 2004 | K042416 | ATHENA MULTI-LYTE ANA-II TEST SYSTEM Zeus Scientific, Inc. | LKJ |
| Jan 8, 2004 | K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 Corgenix, Inc. | LKJ |
| May 12, 2003 | K030775 | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM Immuno Concepts, N.A. , Ltd. | LKJ |
| Jan 17, 2003 | K024232 | LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 Bio-Rad | LKJ |
| Jan 17, 2003 | K024218 | LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 Bio-Rad | LKJ |
| Jan 13, 2003 | K024223 | LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 Bio-Rad | LKJ |
| Jan 10, 2003 | K024226 | LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 Bio-Rad | LKJ |
| Jun 3, 2002 | K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) Diagnostic Products Corp. | LKJ |
| Apr 24, 2002 | K021103 | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM Zeus Scientific, Inc. | LKJ |
| Dec 10, 2001 | K011244 | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM Zeus Scientific, Inc. | LKJ |
| Oct 25, 1999 | K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM Diamedix Corp. | LKJ |
| Dec 22, 1998 | K984478 | LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 Bio-Rad | LKJ |
| Dec 22, 1998 | K984475 | LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 Bio-Rad | LKJ |
| Dec 22, 1998 | K984473 | LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 Bio-Rad | LKJ |
| Dec 22, 1998 | K984470 | LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 Bio-Rad | LKJ |
| Dec 22, 1998 | K984464 | LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 Bio-Rad | LKJ |
| Sep 27, 1996 | K961815 | QUALITROL ANA CONTROL SERUM SET Consolidated Technologies, Inc. | LKJ |
| Dec 26, 1995 | K954891 | HYTEC AUTOIMMUNE KITS (SS-B) Hycor Biomedical, Inc. | LKJ |
| Dec 26, 1995 | K954392 | HYTEC AUTOIMMUNE KIT (SS-A) Hycor Biomedical, Inc. | LKJ |
| Dec 15, 1995 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT Helix Diagnostics, Inc. | LKJ |
| Dec 15, 1995 | K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT Helix Diagnostics, Inc. | LKJ |
| Nov 15, 1993 | K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT Shield Diagnostics, Ltd., GB | LKJ |
| Sep 24, 1993 | K931255 | SYNELISA CENP-B ANTIBODIES Elias U.S.A., Inc. | LKJ |
| Aug 23, 1993 | K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. | LKJ |
| Aug 23, 1993 | K932302 | SYLNELISA HISTONE ANTIBODIES Elias U.S.A., Inc. | LKJ |
| Dec 1, 1992 | K921132 | SYN ELISA DSDNA ANTIBODIES Elias U.S.A., Inc. | LKJ |
| May 22, 1992 | K914454 | THE THERATEST EL-ANA PROFILES Theratest Laboratories, Inc. | LKJ |
| May 1, 1992 | K913342 | AUTOSTAT(TM) ANTI-DSNA Cogent Diagnotics , Ltd., GB | LKJ |
| Mar 18, 1992 | K920150 | ENCORE SCL-70 Clark Laboratories, Inc. | LKJ |
| Feb 11, 1992 | K914550 | ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM Diagnostic Resources, Inc. | LKJ |
| Jul 30, 1991 | K912291 | DISTAT ANTI-SCL-70 KIT Shield Diagnostics, Ltd., GB | LKJ |
| Aug 2, 1989 | K894411 | SERATEST ENA [SCL-70] KIT Hemagen Diagnostics, Inc. | LKJ |
| Jul 14, 1989 | K893896 | QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA Biostar Medical Products, Inc. | LKJ |
| Jun 23, 1989 | K893897 | SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM Biostar Medical Products, Inc. | LKJ |
| Apr 14, 1989 | K885224 | ANA-5 AUTOANTIBODY PROFILE KIT Autoimmunity Diagnostics Corp. | LKJ |
| Oct 27, 1988 | K883949 | ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) Immco Diagnostics, Inc. | LKJ |
| Oct 27, 1988 | K883883 | ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) Immco Diagnostics, Inc. | LKJ |
| Sep 22, 1988 | K882740 | ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY Lipogen, Inc. | LKJ |
| Nov 4, 1987 | K874115 | NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) Sigma Diagnostics, Inc. | LKJ |
| Sep 22, 1987 | K873249 | ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS Cytotech, Inc. | LKJ |
| Mar 12, 1987 | K864668 | ANA TEST KIT Val Tech Diagnostics, Inc. | LKJ |
| Aug 6, 1986 | K862313 | KALLESTAD SM/RNP TEST REAGENT Kallestad Laboratories, Inc. | LKJ |
| Oct 25, 1984 | K842563 | SERATEST DNA DETERMINATION Seragen Diagnostics, Inc. | LKJ |
| Jul 11, 1984 | K842484 | LEAP LE TEST KIT Cooper Biomedical, Inc. | LKJ |
| Jun 8, 1983 | K831463 | ANA-CHECK Diagnostic Technology, Inc. | LKJ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.