Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120
FDA 510(k) K090760 · Theratest Laboratories, Inc.
510(k) numberK090760
Submission
- Device name
- Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120
- Applicant
- Theratest Laboratories, Inc.
Lombard, IL, US - Received
- March 23, 2009
- Decision date
- September 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JZO – System, Test, Thyroid Autoantibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5870
- Specialty
- Immunology
Other 510(k)s with product code JZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/17/2025SE |
| K240469 | Access TPO AntibodyJZO · Traditional | Beckman Coulter, Inc. | 08/09/2024SE |
| K213517 | Access Thyroglobulin Antibody IIJZO · Traditional | Beckman Coulter, Inc. | 09/26/2023SE |
| K222610 | Elecsys Anti-TgJZO · Traditional | Roche Diagnostics | 09/15/2023SE |
| K193313 | Elecsys Anti-TSHRJZO · Traditional | Roche Diagnostics | 02/27/2020SE |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…JZO · Traditional | Phadia AB | 03/25/2016SE |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/03/2016SE |
| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/18/2010SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/21/2009SE |
| K080092 | Elecsys Anti-Tshr Immunoassay, Elecsys Precicontrol ThyroabJZO · Traditional | Roche Diagnostics Corp. | 07/28/2008SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K090753 | Theratest EL-ANTI-CCP/2NHX · Traditional | 03/05/2010SE |
| K071692 | Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test SystemsMVM · Traditional | 11/05/2007SE |
| K061376 | El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3MOB · Traditional | 07/20/2006SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | 02/07/2006SE |
| K051066 | Theratest El-Ana ProfilesLKP · Traditional | 10/07/2005SE |
| K040291 | El-Ana Profiles: Anti-ChromatinLJM · Traditional | 03/11/2004SE |
| K024151 | El-Ana Profiles: Anti-Ribosomal Protein PMQA · Traditional | 02/06/2003SE |
| K024031 | The Theratest El-Ana Profiles: Anti-CentromereLJM · Traditional | 02/06/2003SE |
| K002559 | El-Ana PROFILES-2K1LJM · Traditional | 09/12/2000SE |
| K982622 | El-Ana Profiles: EL-ENA/5LLL · Traditional | 08/13/1998SE |
Questions and answers
When was Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120 cleared by the FDA?
Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120 (K090760) received a 510(k) decision of Substantially Equivalent on September 3, 2009, 164 days after the submission was received.
What is the product code of K090760?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.