Panels › Immunology › Product code JZO · Class 2
System, Test, Thyroid Autoantibody
Regulation 866.5870
0510(k)s in 12 months (92 all time)
1recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in JZO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2025 | K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II Siemens Healthcare Diagnostics, Inc. | JZO |
| Aug 9, 2024 | K240469 | Access TPO Antibody Beckman Coulter, Inc. | JZO |
| Sep 26, 2023 | K213517 | Access Thyroglobulin Antibody II Beckman Coulter, Inc. | JZO |
| Sep 15, 2023 | K222610 | Elecsys Anti-Tg Roche Diagnostics | JZO |
| Feb 27, 2020 | K193313 | Elecsys Anti-TSHR Roche Diagnostics | JZO |
| Mar 25, 2016 | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 25 Phadia AB, SE | JZO |
| Mar 3, 2016 | K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material Siemens Healthcare Diagnostics, Inc. | JZO |
| May 18, 2010 | K092229 | THYRETAIN TM TSI REPORTER BIOASSAY Diagnostic Hybrids, Inc. | JZO |
| Sep 3, 2009 | K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 Theratest Laboratories, Inc. | JZO |
| May 21, 2009 | K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY Diagnostic Hybrids, Inc. | JZO |
| Jul 28, 2008 | K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB Roche Diagnostics Corp. | JZO |
| May 22, 2008 | K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT Kronus Market Development Associates, Inc. | JZO |
| Nov 21, 2006 | K061794 | FIDIS TM THYRO, MODEL MX002 Biomedical Diagnostics (Bmd) SA, FR | JZO |
| Jul 18, 2006 | K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS Fisher Diagnostics | JZO |
| Jul 6, 2006 | K061382 | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 Beckman Coulter, Inc. | JZO |
| May 10, 2006 | K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM Fisher Diagnostics | JZO |
| Feb 7, 2006 | K053426 | ROCHE ELECSYS ANTI-TG Roche Diagnostics Corp. | JZO |
| Aug 4, 2005 | K051890 | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO Roche Diagnostics Corp. | JZO |
| Mar 22, 2004 | K033977 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM Zeus Scientific, Inc. | JZO |
| Mar 22, 2004 | K033454 | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN Brahms Diagnostica, LLC | JZO |
| Sep 10, 2003 | K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT Kronus Market Development Associates, Inc. | JZO |
| Feb 6, 2003 | K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) Quest Intl., Inc. | JZO |
| Aug 5, 2002 | K020672 | ELECSYS ANTI-TG TEST SYSTEM Roche Diagnostics Corp. | JZO |
| May 2, 2002 | K020687 | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 Axis-Shield Diagnostics, Ltd., GB | JZO |
| May 2, 2002 | K020349 | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS Axis-Shield Diagnostics, Ltd., GB | JZO |
| May 2, 2002 | K020348 | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS Axis-Shield Diagnostics, Ltd., GB | JZO |
| Oct 22, 2001 | K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS Bayer Corp. | JZO |
| Jun 6, 2001 | K011082 | TPO IGG ANTIBODY EIA TEST Scimedx Corp. | JZO |
| May 30, 2001 | K011415 | ALPCO MILENIA ANTI-TG EIA American Laboratory Products Co., Ltd. | JZO |
| May 24, 2001 | K011201 | ALPCO MILENIA ANTI-TPO ELISA American Laboratory Products Co., Ltd. | JZO |
| Dec 5, 2000 | K003291 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY Bayer Diagnostics Corp. | JZO |
| Nov 27, 2000 | K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, Pharmacia & Upjohn Co. | JZO |
| May 17, 2000 | K000155 | ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM Roche Diagnostics Corp. | JZO |
| Mar 17, 2000 | K000287 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO Brahms Diagnostica, LLC | JZO |
| Mar 17, 2000 | K000286 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TG Brahms Diagnostica, LLC | JZO |
| Feb 18, 2000 | K000362 | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | JZO |
| Jan 5, 2000 | K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 Pharmacia & Upjohn Co. | JZO |
| Nov 12, 1999 | K992791 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO Brahms Diagnostica, LLC | JZO |
| Nov 12, 1999 | K992790 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG Brahms Diagnostica, LLC | JZO |
| May 13, 1999 | K991096 | IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 Diagnostic Products Corp. | JZO |
| May 13, 1999 | K991094 | IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 Diagnostic Products Corp. | JZO |
| Feb 2, 1999 | K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | JZO |
| Feb 2, 1999 | K984165 | ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. | JZO |
| Feb 2, 1999 | K984163 | ANTI-TPO EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. | JZO |
| Jan 26, 1999 | K983992 | NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY Nichols Institute Diagnostics | JZO |
| Dec 7, 1998 | K983553 | ANTI-TG IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | JZO |
| Oct 16, 1998 | K982866 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 Nichols Institute Diagnostics | JZO |
| Oct 8, 1998 | K981522 | AIA-PACK TGAB ASSAY Tosoh Medics, Inc. | JZO |
| Oct 8, 1998 | K981521 | AIA-PACK TPOAB ASSAY Tosoh Medics, Inc. | JZO |
| Jul 7, 1998 | K981930 | UNICAP THYROID PEROXIDASE IGG Pharmacia & Upjohn Co. | JZO |
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