FDA 510(k) Applications for Medical Device Product Code "JZO"
(System, Test, Thyroid Autoantibody)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K011415 | AMERICAN LABORATORY PRODUCTS CO., LTD. | ALPCO MILENIA ANTI-TG EIA | 05/30/2001 |
| K011201 | AMERICAN LABORATORY PRODUCTS CO., LTD. | ALPCO MILENIA ANTI-TPO ELISA | 05/24/2001 |
| K972190 | AMERICAN LABORATORY PRODUCTS CO., LTD. | THYROGLOBULIN ASSAY SYSTEM | 07/14/1997 |
| K020349 | AXIS-SHIELD DIAGNOSTICS, LTD. | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS | 05/02/2002 |
| K020348 | AXIS-SHIELD DIAGNOSTICS, LTD. | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS | 05/02/2002 |
| K020687 | AXIS-SHIELD DIAGNOSTICS, LTD. | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 | 05/02/2002 |
| K012777 | BAYER CORP. | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS | 10/22/2001 |
| K003291 | BAYER DIAGNOSTICS CORP. | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY | 12/05/2000 |
| K213517 | Beckman Coulter, Inc. | Access Thyroglobulin Antibody II | 09/26/2023 |
| K061382 | BECKMAN COULTER, INC. | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 | 07/06/2006 |
| K061794 | BIOMEDICAL DIAGNOSTICS (BMD) SA | FIDIS TM THYRO, MODEL MX002 | 11/21/2006 |
| K992790 | BRAHMS DIAGNOSTICA, LLC. | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG | 11/12/1999 |
| K992791 | BRAHMS DIAGNOSTICA, LLC. | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO | 11/12/1999 |
| K000286 | BRAHMS DIAGNOSTICA, LLC. | BRAHMS DIAGNOSTICA LUMITEST ANTI-TG | 03/17/2000 |
| K000287 | BRAHMS DIAGNOSTICA, LLC. | BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO | 03/17/2000 |
| K033454 | BRAHMS DIAGNOSTICA, LLC. | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | 03/22/2004 |
| K983553 | COLUMBIA BIOSCIENCE, INC. | ANTI-TG IGG ELISA TEST SYSTEM | 12/07/1998 |
| K984228 | COLUMBIA BIOSCIENCE, INC. | IS ANTI-TPO IGG ELISA TEST SYSTEM | 02/02/1999 |
| K092229 | DIAGNOSTIC HYBRIDS, INC. | THYRETAIN TM TSI REPORTER BIOASSAY | 05/18/2010 |
| K083391 | DIAGNOSTIC HYBRIDS, INC. | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | 05/21/2009 |
| K991094 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 | 05/13/1999 |
| K991096 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 | 05/13/1999 |
| K980206 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE ANTI-TG AB | 05/01/1998 |
| K963695 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ | 01/17/1997 |
| K052308 | FISHER DIAGNOSTICS | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | 05/10/2006 |
| K052407 | FISHER DIAGNOSTICS | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | 07/18/2006 |
| K960370 | IMMCO DIAGNOSTICS, INC. | THYROGLOBULIN ANTIBODY ELISA | 06/20/1996 |
| K960369 | IMMCO DIAGNOSTICS, INC. | THYROID PEROXIDASE ANTIBODY ELISA | 06/20/1996 |
| K080159 | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | 05/22/2008 |
| K032134 | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | 09/10/2003 |
| K982866 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 | 10/16/1998 |
| K983992 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY | 01/26/1999 |
| K151799 | PHADIA AB | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | 03/25/2016 |
| K981559 | PHARMACIA & UPJOHN CO. | UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY | 07/07/1998 |
| K981930 | PHARMACIA & UPJOHN CO. | UNICAP THYROID PEROXIDASE IGG | 07/07/1998 |
| K003414 | PHARMACIA & UPJOHN CO. | VARELISA TG (THYROGLOBULIN) ANTIBODIES, | 11/27/2000 |
| K993585 | PHARMACIA & UPJOHN CO. | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | 01/05/2000 |
| K023593 | QUEST INTL., INC. | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | 02/06/2003 |
| K222610 | Roche Diagnostics | Elecsys Anti-Tg | 09/15/2023 |
| K193313 | Roche Diagnostics | Elecsys Anti-TSHR | 02/27/2020 |
| K020672 | ROCHE DIAGNOSTICS CORP. | ELECSYS ANTI-TG TEST SYSTEM | 08/05/2002 |
| K000155 | ROCHE DIAGNOSTICS CORP. | ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM | 05/17/2000 |
| K080092 | ROCHE DIAGNOSTICS CORP. | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | 07/28/2008 |
| K051890 | ROCHE DIAGNOSTICS CORP. | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO | 08/04/2005 |
| K053426 | ROCHE DIAGNOSTICS CORP. | ROCHE ELECSYS ANTI-TG | 02/07/2006 |
| K011082 | SCIMEDX CORP. | TPO IGG ANTIBODY EIA TEST | 06/06/2001 |
| K152061 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | 03/03/2016 |
| K984165 | THE BINDING SITE, LTD. | ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT | 02/02/1999 |
| K984163 | THE BINDING SITE, LTD. | ANTI-TPO EIA DIAGNOSTIC TEST KIT | 02/02/1999 |
| K090760 | THERATEST LABORATORIES, INC. | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | 09/03/2009 |
| K981522 | TOSOH MEDICS, INC. | AIA-PACK TGAB ASSAY | 10/08/1998 |
| K981521 | TOSOH MEDICS, INC. | AIA-PACK TPOAB ASSAY | 10/08/1998 |
| K000362 | ZEUS SCIENTIFIC, INC. | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM | 02/18/2000 |
| K033977 | ZEUS SCIENTIFIC, INC. | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM | 03/22/2004 |
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