JZO — System, Test, Thyroid Autoantibody Class II
FDA product code JZO covers "System, Test, Thyroid Autoantibody", a Class II medical device regulated under 21 CFR 866.5870. 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
- JZO
- Device Class
- Class II
- Regulation Number
- 866.5870
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250250 | siemens healthcare diagnostics | ADVIA Centaur Anti-Thyroid Peroxidase II | October 17, 2025 |
| K240469 | beckman coulter | Access TPO Antibody | August 9, 2024 |
| K213517 | beckman coulter | Access Thyroglobulin Antibody II | September 26, 2023 |
| K222610 | roche diagnostics | Elecsys Anti-Tg | September 15, 2023 |
| K193313 | roche diagnostics | Elecsys Anti-TSHR | February 27, 2020 |
| K151799 | phadia | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Contr | March 25, 2016 |
| K152061 | siemens healthcare diagnostics | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | March 3, 2016 |
| K092229 | diagnostic hybrids | THYRETAIN TM TSI REPORTER BIOASSAY | May 18, 2010 |
| K090760 | theratest laboratories | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-12 | September 3, 2009 |
| K083391 | diagnostic hybrids | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | May 21, 2009 |
| K080092 | roche diagnostics | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | July 28, 2008 |
| K080159 | kronus market development associates | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | May 22, 2008 |
| K061794 | biomedical diagnostics (bmd) | FIDIS TM THYRO, MODEL MX002 | November 21, 2006 |
| K052407 | fisher diagnostics | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | July 18, 2006 |
| K061382 | beckman coulter | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A182 | July 6, 2006 |
| K052308 | fisher diagnostics | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY C | May 10, 2006 |
| K053426 | roche diagnostics | ROCHE ELECSYS ANTI-TG | February 7, 2006 |
| K051890 | roche diagnostics | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO | August 4, 2005 |
| K033977 | zeus scientific | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM | March 22, 2004 |
| K033454 | brahms diagnostica | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | March 22, 2004 |