LKJ — Antinuclear Antibody, Antigen, Control Class II
FDA product code LKJ covers "Antinuclear Antibody, Antigen, Control", a Class II medical device regulated under 21 CFR 866.5100. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKJ
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K210902 | phadia | EliA Ro52, EliA Ro60 | July 27, 2022 |
| K113610 | bio-rad laboratories | ANA-SCREEN WITH MDSS | July 9, 2012 |
| K082759 | phadia us | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMU | April 10, 2009 |
| K081104 | aesku diagnostics | AESKULISA ANA HEP-2, REF 30-7115US | May 2, 2008 |
| K041658 | bio-rad laboratories | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL | December 20, 2004 |
| K042416 | zeus scientific | ATHENA MULTI-LYTE ANA-II TEST SYSTEM | October 8, 2004 |
| K034013 | corgenix | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | January 8, 2004 |
| K030775 | immuno concepts, n.a. | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | May 12, 2003 |
| K024232 | bio-rad | LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 | January 17, 2003 |
| K024218 | bio-rad | LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 | January 17, 2003 |
| K024223 | bio-rad | LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 | January 13, 2003 |
| K024226 | bio-rad | LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 | January 10, 2003 |
| K021257 | diagnostic products | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | June 3, 2002 |
| K021103 | zeus scientific | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM | April 24, 2002 |
| K011244 | zeus scientific | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM | December 10, 2001 |
| K993294 | diamedix | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | October 25, 1999 |
| K984473 | bio-rad | LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 | December 22, 1998 |
| K984464 | bio-rad | LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 | December 22, 1998 |
| K984470 | bio-rad | LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 | December 22, 1998 |
| K984475 | bio-rad | LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 | December 22, 1998 |