JZO — System, Test, Thyroid Autoantibody Class II
FDA Device Classification
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 |
| K033454 | brahms diagnostica | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | March 22, 2004 |
| K033977 | zeus scientific | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM | March 22, 2004 |