LJM — Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Class II
FDA product code LJM covers "Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls", 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
- LJM
- 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 |
|---|---|---|---|
| K182353 | phadia | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | November 27, 2018 |
| K151559 | immco diagnostics | ImmuLisa Enhanced Centromere Antibody ELISA | March 11, 2016 |
| K140493 | phadia | ELIA SCL-70S IMMUNOASSAY | October 30, 2014 |
| K123880 | inova diagnostics | QUANTA FLASH CENTROMERE | February 7, 2014 |
| K131330 | gold standard diagnostics | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | January 28, 2014 |
| K131185 | euroimmun us | ANA SCREEN ELISA (IGG) | July 15, 2013 |
| K083188 | phadia us | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | March 13, 2009 |
| K050967 | sweden diagnostics (germany) | VARELISA RECOMBI CTD SCREEN, MODEL 13096 | June 28, 2005 |
| K050625 | sweden diagnostics (germany) | VARELISA RECOMBI ANA PROFILE, MODEL 18496 | April 26, 2005 |
| K041102 | immco diagnostics | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | October 26, 2004 |
| K040953 | aesku | AESKULISA ANA HEP-2 | June 23, 2004 |
| K040810 | pharmacia deutschland | VARELISA HISTONE ANTIBODIES, MODEL 16496 | May 14, 2004 |
| K040291 | theratest laboratories | EL-ANA PROFILES: ANTI-CHROMATIN | March 11, 2004 |
| K040200 | rhigene | MESACUP-2 TEST CENP-B | March 4, 2004 |
| K030929 | orgentec diagnostika | ANA DETECT | May 2, 2003 |
| K024031 | theratest laboratories | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | February 6, 2003 |
| K022018 | rhigene | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | July 5, 2002 |
| K004019 | binding site | ANA EIA DIAGNOSTIC TEST KIT | February 15, 2001 |
| K003959 | inova diagnostics | QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA | January 22, 2001 |
| K002559 | theratest laboratories | EL-ANA PROFILES-2K1 | September 12, 2000 |