LLL — Extractable Antinuclear Antibody, Antigen And Control Class II
FDA product code LLL covers "Extractable Antinuclear Antibody, Antigen And 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
- LLL
- 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 |
|---|---|---|---|
| K253367 | phadia | EliA CTD 13 Screen | June 25, 2026 |
| K250666 | zeus scientific | Alegria Flash CTD Screen | October 22, 2025 |
| K250408 | zeus scientific | Alegria Flash ENA Screen | September 19, 2025 |
| K213403 | inova diagnostics | Aptiva CTD Essential Reagent | September 29, 2023 |
| K190710 | phadia | EliA SymphonyS Immunoassay | November 29, 2019 |
| K180975 | inova diagnostics | QUANTA Flash HMGCR Reagents | June 25, 2018 |
| K152635 | inova diagnostics | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Contro | June 1, 2016 |
| K151429 | inova diagnostics | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrol | February 12, 2016 |
| K142781 | immco diagnostics | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody | March 31, 2015 |
| K141328 | inova diagnostics | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | February 12, 2015 |
| K141210 | inova diagnostics | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | January 29, 2015 |
| K122923 | inova diagnostics | QUANTA FLASH ENA7 | May 7, 2013 |
| K112996 | euroimmun us | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | April 9, 2013 |
| K113143 | immco diagnostics | IMMULISA SCI-70 ANTIBODY ELISA | December 2, 2011 |
| K102607 | biomedical diagnostics (bmd) | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | December 3, 2010 |
| K072149 | phadia us | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | January 15, 2008 |
| K053653 | biomedical diagnostics (bmd) | FIDIS CONNECTIVE 10, MODEL MX006 | March 13, 2006 |
| K050286 | biomedical diagnostics (bmd) | FIDIS CONNECTIVE 8 | October 3, 2005 |
| K043067 | bioarray solutions | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 | May 31, 2005 |
| K041753 | aesku diagnostics | AESKULISA ENA 6 S | July 14, 2004 |