FDA Product Code
FDA Product Code JZO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5870
510(k) Clearances — 92 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 | Traditional | PDF ↗ |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024-08-09 | Traditional | PDF ↗ |
| K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023-09-26 | Traditional | PDF ↗ |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023-09-15 | Traditional | PDF ↗ |
| K193313 | Elecsys Anti-TSHR | Roche Diagnostics | 2020-02-27 | Traditional | PDF ↗ |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | Phadia AB | 2016-03-25 | Traditional | PDF ↗ |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2016-03-03 | Traditional | PDF ↗ |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | Diagnostic Hybrids, Inc. | 2010-05-18 | Traditional | PDF ↗ |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | Theratest Laboratories, Inc. | 2009-09-03 | Traditional | PDF ↗ |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | Diagnostic Hybrids, Inc. | 2009-05-21 | Traditional | PDF ↗ |
| K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | Roche Diagnostics Corp. | 2008-07-28 | Traditional | PDF ↗ |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-05-22 | Traditional | PDF ↗ |
| K061794 | FIDIS TM THYRO, MODEL MX002 | Biomedical Diagnostics (Bmd) SA | 2006-11-21 | Traditional | PDF ↗ |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | Fisher Diagnostics | 2006-07-18 | Traditional | PDF ↗ |
| K061382 | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 | Beckman Coulter, Inc. | 2006-07-06 | Traditional | PDF ↗ |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | Fisher Diagnostics | 2006-05-10 | Traditional | PDF ↗ |
| K053426 | ROCHE ELECSYS ANTI-TG | Roche Diagnostics Corp. | 2006-02-07 | Special | PDF ↗ |
| K051890 | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO | Roche Diagnostics Corp. | 2005-08-04 | Special | PDF ↗ |
| K033977 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM | Zeus Scientific, Inc. | 2004-03-22 | Traditional | PDF ↗ |
| K033454 | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | Brahms Diagnostica, LLC | 2004-03-22 | Traditional | PDF ↗ |
| K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | Kronus Market Development Associates, Inc. | 2003-09-10 | Traditional | PDF ↗ |
| K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | Quest Intl., Inc. | 2003-02-06 | Traditional | PDF ↗ |
| K020672 | ELECSYS ANTI-TG TEST SYSTEM | Roche Diagnostics Corp. | 2002-08-05 | Traditional | PDF ↗ |
| K020349 | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | Traditional | PDF ↗ |
| K020348 | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | Traditional | PDF ↗ |
| K020687 | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | Traditional | PDF ↗ |
| K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS | Bayer Corp. | 2001-10-22 | Traditional | PDF ↗ |
| K011082 | TPO IGG ANTIBODY EIA TEST | Scimedx Corp. | 2001-06-06 | Traditional | PDF ↗ |
| K011415 | ALPCO MILENIA ANTI-TG EIA | American Laboratory Products Co., Ltd. | 2001-05-30 | Traditional | PDF ↗ |
| K011201 | ALPCO MILENIA ANTI-TPO ELISA | American Laboratory Products Co., Ltd. | 2001-05-24 | Traditional | PDF ↗ |
| K003291 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY | Bayer Diagnostics Corp. | 2000-12-05 | Traditional | PDF ↗ |
| K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, | Pharmacia & Upjohn Co. | 2000-11-27 | Traditional | PDF ↗ |
| K000155 | ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM | Roche Diagnostics Corp. | 2000-05-17 | Traditional | PDF ↗ |
| K000287 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO | Brahms Diagnostica, LLC | 2000-03-17 | Traditional | PDF ↗ |
| K000286 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TG | Brahms Diagnostica, LLC | 2000-03-17 | Traditional | PDF ↗ |
| K000362 | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 2000-02-18 | Special | PDF ↗ |
| K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | Pharmacia & Upjohn Co. | 2000-01-05 | Traditional | PDF ↗ |
| K992791 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO | Brahms Diagnostica, LLC | 1999-11-12 | Traditional | PDF ↗ |
| K992790 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG | Brahms Diagnostica, LLC | 1999-11-12 | Traditional | PDF ↗ |
| K991094 | IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 | Diagnostic Products Corp. | 1999-05-13 | Special | PDF ↗ |
| K991096 | IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 | Diagnostic Products Corp. | 1999-05-13 | Special | PDF ↗ |
| K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K984163 | ANTI-TPO EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-02 | Traditional | PDF ↗ |
| K984165 | ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-02 | Traditional | PDF ↗ |
| K983992 | NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY | Nichols Institute Diagnostics | 1999-01-26 | Traditional | PDF ↗ |
| K983553 | ANTI-TG IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-12-07 | Traditional | PDF ↗ |
| K982866 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 | Nichols Institute Diagnostics | 1998-10-16 | Traditional | PDF ↗ |
| K981522 | AIA-PACK TGAB ASSAY | Tosoh Medics, Inc. | 1998-10-08 | Traditional | PDF ↗ |
| K981521 | AIA-PACK TPOAB ASSAY | Tosoh Medics, Inc. | 1998-10-08 | Traditional | PDF ↗ |
| K981559 | UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY | Pharmacia & Upjohn Co. | 1998-07-07 | Traditional | PDF ↗ |
| K981930 | UNICAP THYROID PEROXIDASE IGG | Pharmacia & Upjohn Co. | 1998-07-07 | Traditional | PDF ↗ |
| K980206 | IMMULITE ANTI-TG AB | Diagnostic Products Corp. | 1998-05-01 | Traditional | PDF ↗ |
| K972190 | THYROGLOBULIN ASSAY SYSTEM | American Laboratory Products Co., Ltd. | 1997-07-14 | Traditional | PDF ↗ |
| K963695 | IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ | Diagnostic Products Corp. | 1997-01-17 | Traditional | PDF ↗ |
| K960369 | THYROID PEROXIDASE ANTIBODY ELISA | Immco Diagnostics, Inc. | 1996-06-20 | Traditional | PDF ↗ |
| K960370 | THYROGLOBULIN ANTIBODY ELISA | Immco Diagnostics, Inc. | 1996-06-20 | Traditional | PDF ↗ |
| K951487 | DIASTAT ANTI-THYROID PEROXIDASE KIT | Shield Diagnostics, Ltd. | 1995-06-30 | Traditional | PDF ↗ |
| K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | Shield Diagnostics, Ltd. | 1995-06-30 | Traditional | PDF ↗ |
| K952130 | ORGENTEC ANTI-TG ELISA | American Laboratory Products Co., Ltd. | 1995-06-20 | Traditional | PDF ↗ |
| K952129 | ORGENTEC ANTI-TPO ELISA | American Laboratory Products Co., Ltd. | 1995-06-20 | Traditional | PDF ↗ |
| K950217 | ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-24 | Traditional | PDF ↗ |
| K950090 | ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-21 | Traditional | PDF ↗ |
| K950089 | ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-21 | Traditional | PDF ↗ |
| K950088 | ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) | American Laboratory Products Co., Ltd. | 1995-04-21 | Traditional | PDF ↗ |
| K931311 | THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT | Nichols Institute | 1993-05-14 | Traditional | PDF ↗ |
| K930485 | QUANTA LITE(TM) THYROID M ELISA | Inova Diagnostics, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K930274 | THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME | Joldon Diagnostics | 1993-02-23 | Traditional | PDF ↗ |
| K925194 | THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT | Joldon Diagnostics | 1993-02-05 | Traditional | PDF ↗ |
| K925826 | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA | Clark Laboratories, Inc. | 1993-01-26 | Traditional | PDF ↗ |
| K925785 | AUTOSTAT ANTI-THYROID MICROSOMAL KIT | Cogent Diagnotics , Ltd. | 1993-01-21 | Traditional | PDF ↗ |
| K925784 | AUTOSTAT ANTITHYROGLOBIN | Cogent Diagnotics , Ltd. | 1993-01-21 | Traditional | PDF ↗ |
| K925923 | ELIAS TMAB | Elias U.S.A., Inc. | 1993-01-14 | Traditional | PDF ↗ |
| K925922 | ELIAS TGAB | Elias U.S.A., Inc. | 1993-01-14 | Traditional | PDF ↗ |
| K915133 | SYNELISA TMAB | Elias U.S.A., Inc. | 1992-04-08 | Traditional | PDF ↗ |
| K915134 | SYNELISA TGAB | Elias U.S.A., Inc. | 1992-04-08 | Traditional | PDF ↗ |
| K915135 | SYNELISA TGAB/TMAB | Elias U.S.A., Inc. | 1992-04-08 | Traditional | PDF ↗ |
| K915429 | KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT | Kronus | 1992-03-30 | Traditional | PDF ↗ |
| K915428 | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT | Kronus | 1992-03-30 | Traditional | PDF ↗ |
| K905485 | IMMUNOWELL THYROGLOBULIN TEST | General Biometrics, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K904224 | NOVA LITE TM THYROID | Inova Diagnostics, Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K894364 | MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) | Kronus | 1989-07-25 | Traditional | PDF ↗ |
| K894203 | ANTI-THYROGLOBULIN TEST KIT | Kronus | 1989-07-25 | Traditional | PDF ↗ |
| K881933 | KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-06-06 | Traditional | PDF ↗ |
| K871193 | I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT | Cronus | 1987-05-15 | Traditional | PDF ↗ |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | Miles Laboratories, Inc. | 1987-02-18 | Traditional | PDF ↗ |
| K863006 | 125-I TSH RECEPTOR ANTIBODY KIT | Cronus | 1986-09-08 | Traditional | PDF ↗ |
| K843343 | MEDICA IIF-ANTI-THYROID ANTIBODY TEST | Medical Diagnostics, Ca. | 1984-10-22 | Traditional | PDF ↗ |
| K841580 | TSH RECEPTOR ANTIBODY KIT 125I TSH | Clinetics Corp. | 1984-10-22 | Traditional | PDF ↗ |
| K821489 | CORDIA TG | Cordis Corp. | 1982-06-09 | Traditional | PDF ↗ |
| K810982 | ANTITHYROID ANTIBODY IMMUNOFLUORESCENT | Immuno-Products Industries | 1981-05-01 | Traditional | PDF ↗ |
| K791458 | AGGLUTINOTEST-THYROGLOBULIN | Volu Sol Medical Industries | 1979-12-31 | Traditional | PDF ↗ |
| K760154 | TEST, (IVDP) THYROID ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code JZO · Class II · Immunology. Data: openFDA.