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 |
| 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 |
| K961815 | CONSOLIDATED TECHNOLOGIES, INC. | QUALITROL ANA CONTROL SERUM SET | 09/27/1996 |
| K034013 | CORGENIX, INC. | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | 01/08/2004 |
| K021257 | DIAGNOSTIC PRODUCTS CORP. | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | 06/03/2002 |
| K993294 | DIAMEDIX CORP. | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | 10/25/1999 |
| K030775 | IMMUNO CONCEPTS, N.A., LTD | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | 05/12/2003 |
| K210902 | Phadia AB | EliA Ro52, EliA Ro60 | 07/27/2022 |
| K082759 | PHADIA US INC. | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | 04/10/2009 |
| 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
