Encore Thyroglobulin Ige, Iga and Igm Eia
FDA 510(k) K925826 · Clark Laboratories, Inc.
510(k) numberK925826
Submission
- Device name
- Encore Thyroglobulin Ige, Iga and Igm Eia
- Applicant
- Clark Laboratories, Inc.
Blairstown, NJ, US - Received
- November 16, 1992
- Decision date
- January 26, 1993
- 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 |
|---|---|---|
| K980912 | Vca Igg Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980596 | Vca Igm Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | 05/01/1998SE |
| K973123 | Ea-D Igg Elisa Test SystemLSE · Traditional | 03/26/1998SE |
| K931543 | Encore Ena Combined EiaLLL · Traditional | 09/08/1993SE |
| K923537 | Encore Ds-DnaLRM · Traditional | 12/23/1992SE |
| K921870 | Encore Sm/RnpLLL · Traditional | 12/01/1992SE |
| K921572 | Encore SMLLL · Traditional | 12/01/1992SE |
| K922340 | Encore Ss-BLLL · Traditional | 10/16/1992SE |
| K922157 | Encore Ss-ALLL · Traditional | 10/13/1992SE |
Questions and answers
When was Encore Thyroglobulin Ige, Iga and Igm Eia cleared by the FDA?
Encore Thyroglobulin Ige, Iga and Igm Eia (K925826) received a 510(k) decision of Substantially Equivalent on January 26, 1993, 71 days after the submission was received.
What is the product code of K925826?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.