FDA Product Code
FDA Product Code LKJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60 | Phadia AB | 2022-07-27 | Traditional | PDF ↗ |
| K113610 | ANA-SCREEN WITH MDSS | Bio-Rad Laboratories | 2012-07-09 | Special | PDF ↗ |
| K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | Phadia US, Inc. | 2009-04-10 | Traditional | PDF ↗ |
| K081104 | AESKULISA ANA HEP-2, REF 30-7115US | Aesku Diagnostics | 2008-05-02 | Traditional | PDF ↗ |
| K041658 | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 | Bio-Rad Laboratories, Inc. | 2004-12-20 | Traditional | PDF ↗ |
| K042416 | ATHENA MULTI-LYTE ANA-II TEST SYSTEM | Zeus Scientific, Inc. | 2004-10-08 | Special | PDF ↗ |
| K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | Corgenix, Inc. | 2004-01-08 | Special | PDF ↗ |
| K030775 | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | Immuno Concepts, N.A. , Ltd. | 2003-05-12 | Abbreviated | PDF ↗ |
| K024218 | LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 | Bio-Rad | 2003-01-17 | Traditional | PDF ↗ |
| K024232 | LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 | Bio-Rad | 2003-01-17 | Traditional | PDF ↗ |
| K024223 | LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | 2003-01-13 | Traditional | PDF ↗ |
| K024226 | LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | 2003-01-10 | Traditional | PDF ↗ |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Diagnostic Products Corp. | 2002-06-03 | Traditional | PDF ↗ |
| K021103 | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | 2002-04-24 | Special | PDF ↗ |
| K011244 | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | 2001-12-10 | Traditional | PDF ↗ |
| K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | Diamedix Corp. | 1999-10-25 | Traditional | PDF ↗ |
| K984470 | LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K984475 | LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K984478 | LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K984473 | LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K984464 | LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K961815 | QUALITROL ANA CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-27 | Traditional | PDF ↗ |
| K954891 | HYTEC AUTOIMMUNE KITS (SS-B) | Hycor Biomedical, Inc. | 1995-12-26 | Traditional | PDF ↗ |
| K954392 | HYTEC AUTOIMMUNE KIT (SS-A) | Hycor Biomedical, Inc. | 1995-12-26 | Traditional | PDF ↗ |
| K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT | Helix Diagnostics, Inc. | 1995-12-15 | Traditional | PDF ↗ |
| K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | Helix Diagnostics, Inc. | 1995-12-15 | Traditional | PDF ↗ |
| K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT | Shield Diagnostics, Ltd. | 1993-11-15 | Traditional | PDF ↗ |
| K931255 | SYNELISA CENP-B ANTIBODIES | Elias U.S.A., Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K932302 | SYLNELISA HISTONE ANTIBODIES | Elias U.S.A., Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT | Biowhittaker Molecular Applications, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K921132 | SYN ELISA DSDNA ANTIBODIES | Elias U.S.A., Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K914454 | THE THERATEST EL-ANA PROFILES | Theratest Laboratories, Inc. | 1992-05-22 | Traditional | PDF ↗ |
| K913342 | AUTOSTAT(TM) ANTI-DSNA | Cogent Diagnotics , Ltd. | 1992-05-01 | Traditional | PDF ↗ |
| K920150 | ENCORE SCL-70 | Clark Laboratories, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K914550 | ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM | Diagnostic Resources, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K912291 | DISTAT ANTI-SCL-70 KIT | Shield Diagnostics, Ltd. | 1991-07-30 | Traditional | PDF ↗ |
| K894411 | SERATEST ENA [SCL-70] KIT | Hemagen Diagnostics, Inc. | 1989-08-02 | Traditional | PDF ↗ |
| K893896 | QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA | Biostar Medical Products, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K893897 | SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM | Biostar Medical Products, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K885224 | ANA-5 AUTOANTIBODY PROFILE KIT | Autoimmunity Diagnostics Corp. | 1989-04-14 | Traditional | PDF ↗ |
| K883949 | ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) | Immco Diagnostics, Inc. | 1988-10-27 | Traditional | PDF ↗ |
| K883883 | ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) | Immco Diagnostics, Inc. | 1988-10-27 | Traditional | PDF ↗ |
| K882740 | ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY | Lipogen, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K874115 | NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) | Sigma Diagnostics, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K873249 | ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS | Cytotech, Inc. | 1987-09-22 | Traditional | PDF ↗ |
| K864668 | ANA TEST KIT | Val Tech Diagnostics, Inc. | 1987-03-12 | Traditional | PDF ↗ |
| K862313 | KALLESTAD SM/RNP TEST REAGENT | Kallestad Laboratories, Inc. | 1986-08-06 | Traditional | PDF ↗ |
| K842563 | SERATEST DNA DETERMINATION | Seragen Diagnostics, Inc. | 1984-10-25 | Traditional | PDF ↗ |
| K842484 | LEAP LE TEST KIT | Cooper Biomedical, Inc. | 1984-07-11 | Traditional | PDF ↗ |
| K831463 | ANA-CHECK | Diagnostic Technology, Inc. | 1983-06-08 | Traditional | PDF ↗ |
Product code LKJ · Class II · Immunology. Data: openFDA.