Is Anti-Tpo Igg Elisa Test System
FDA 510(k) K984228 · Columbia Bioscience, Inc.
510(k) numberK984228
Submission
- Device name
- Is Anti-Tpo Igg Elisa Test System
- Applicant
- Columbia Bioscience, Inc.
Columbia, MD, US - Received
- November 25, 1998
- Decision date
- February 2, 1999
- 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 |
|---|---|---|
| K991274 | Mumps Igg Elisa Test SystemLJY · Traditional | 09/03/1999SE |
| K990462 | Is H. Pylori Igg Elisa Test SystemLYR · Traditional | 09/03/1999SE |
| K983606 | Is Borrelia Burgdorferi Igm Test SystemLSR · Traditional | 12/16/1998SE |
| K983605 | Is Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 12/16/1998SE |
| K983553 | Anti-Tg Igg Elisa Test SystemJZO · Traditional | 12/07/1998SE |
| K982352 | Vca Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982350 | Ea-D Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982348 | EBNA-1 Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K983740 | IS-ANTI-PR3 Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
| K983390 | Is-Anti-Mpo Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
Questions and answers
When was Is Anti-Tpo Igg Elisa Test System cleared by the FDA?
Is Anti-Tpo Igg Elisa Test System (K984228) received a 510(k) decision of Substantially Equivalent on February 2, 1999, 69 days after the submission was received.
What is the product code of K984228?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.