Fidis TM Thyro, Model MX002
FDA 510(k) K061794 · Biomedical Diagnostics (Bmd) SA
510(k) numberK061794
Submission
- Device name
- Fidis TM Thyro, Model MX002
- Applicant
- Biomedical Diagnostics (Bmd) SA
Marne La Vallee Cedex 2, FR - Received
- June 26, 2006
- Decision date
- November 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | Theratest Laboratories, Inc. | 09/03/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/21/2009SE |
More from Diagnostic Hybrids, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102607 | Fidistm Connective 10, Fidistm Analyzer, CarisLLL · Traditional | 12/03/2010SE |
| K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris SystemMOB · Special | 11/03/2010SE |
| K070458 | Modification to Fidis Vasculitis, Model MX007MOB · Traditional | 12/21/2007SE |
| K071210 | Modification to Fidis Connective 10*, Model MX006LKO · Traditional | 12/19/2007SE |
| K060380 | Fidis DsdnaLSW · Traditional | 05/02/2006SE |
| K053383 | Fidis CeliacMST · Traditional | 03/29/2006SE |
| K053653 | Fidis Connective 10, Model MX006LLL · Traditional | 03/13/2006SE |
| K053012 | Fidis Vasculitis, Model MX007MOB · Traditional | 03/02/2006SE |
| K050286 | Fidis Connective 8LLL · Traditional | 10/03/2005SE |
Questions and answers
When was Fidis TM Thyro, Model MX002 cleared by the FDA?
Fidis TM Thyro, Model MX002 (K061794) received a 510(k) decision of Substantially Equivalent on November 21, 2006, 148 days after the submission was received.
What is the product code of K061794?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.