Varelisa TG (Thyroglobulin) Antibodies,
FDA 510(k) K003414 · Pharmacia & Upjohn Co.
510(k) numberK003414
Submission
- Device name
- Varelisa TG (Thyroglobulin) Antibodies,
- Applicant
- Pharmacia & Upjohn Co.
Westervillle, OH, US - Received
- November 2, 2000
- Decision date
- November 27, 2000
- 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 |
|---|---|---|
| K002556 | Ceeon Easysert Intraocular Lens Injector, Model IMP-1MSS · Traditional | 10/31/2000SE |
| K000312 | Varelisa SM AntibodiesLKP · Traditional | 03/17/2000SE |
| K000132 | Allergen Immunocap, Models C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73…DHB · Traditional | 02/18/2000SE |
| K993585 | Varelisa Tpo Antibodies, Model 12348/12396JZO · Traditional | 01/05/2000SE |
| K993388 | Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59…DHB · Traditional | 12/01/1999SE |
| K993589 | Varelisa RNP AntibodiesLKO · Traditional | 11/26/1999SE |
| K993109 | Varelisa Recombi Ana ProfileLJM · Traditional | 11/12/1999SE |
| K993108 | Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96LJM · Traditional | 11/12/1999SE |
| K991945 | Pharmacia Cap System Ige Feia, Model 10-9395-01DGC · Traditional | 07/28/1999SE |
| K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216…DHB · Traditional | 05/14/1999SE |
Questions and answers
When was Varelisa TG (Thyroglobulin) Antibodies, cleared by the FDA?
Varelisa TG (Thyroglobulin) Antibodies, (K003414) received a 510(k) decision of Substantially Equivalent on November 27, 2000, 25 days after the submission was received.
What is the product code of K003414?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.