Thyroglobulin Eia Test Kit
FDA 510(k) K951362 · Immunoprobe, Inc.
510(k) numberK951362
Submission
- Device name
- Thyroglobulin Eia Test Kit
- Applicant
- Immunoprobe, Inc.
Washington, D.C., DC, US - Received
- March 24, 1995
- Decision date
- November 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JNL – Immunochemical, Thyroglobulin Autoantibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5870
- Specialty
- Immunology
Other 510(k)s with product code JNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/04/2025SE |
| K240996 | Access Thyroglobulin Antibody IIJNL · Traditional | Beckman Coulter, Inc. | 07/03/2024SE |
| K112933 | Access Thyroglobulin AnitbodyJNL · Special | Beckman Coulter, Inc. | 12/27/2011SE |
| K072661 | Immunocap Thyrlobulin ImmunocapJNL · Special | Phadia US, Inc. | 11/20/2007SE |
| K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)JNL · Special | Beckman Coulter, Inc. | 10/05/2006SE |
| K971834 | Anti-Thyroid Peroxidase (Tpo) Microplate ElisaJNL · Traditional | Monobind | 07/03/1997SE |
| K962451 | Hy-Tec/Manual Autoimmune Kit for Thyroid Microsomal (Tpo)JNL · Traditional | Hycor Biomedical, Inc. | 11/25/1996SE |
| K962341 | Hy-Tec/Manual Autoimmune Kit for Thyroglobulin (TG)JNL · Traditional | Hycor Biomedical, Inc. | 11/25/1996SE |
| K954256 | Anti-TpoJNL · Traditional | Biomerica, Inc. | 11/27/1995SE |
| K951364 | Microsomal Eia Test KitJNL · Traditional | Immunoprobe, Inc. | 11/20/1995SE |
More from Immunoprobe, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972406 | Adenovirus Antigen Detection Elisa Test SystemGOD · Traditional | 12/22/1997SE |
| K971393 | Mycoplasma Igg Elisa Test SystemLJZ · Traditional | 07/14/1997SE |
| K961765 | Mpo Elisa Test SystemMOB · Traditional | 08/19/1996SE |
| K961764 | PR-3 Elisa Test SystemMOB · Traditional | 08/19/1996SE |
| K951549 | Ebna Igg Eia Test SystemLLM · Traditional | 04/29/1996SE |
| K952523 | Cardiolipin Igg Eia Test KitMID · Traditional | 02/09/1996SE |
| K952522 | Cardiolipin Iga Eia Test SystemMID · Traditional | 02/09/1996SE |
| K952521 | Cardiolipin Igm Eia Test SystemMID · Traditional | 02/09/1996SE |
| K951364 | Microsomal Eia Test KitJNL · Traditional | 11/20/1995SE |
| K951363 | Cardiolipin Igg,M,A Eia Test SystemMID · Traditional | 10/13/1995SE |
Questions and answers
When was Thyroglobulin Eia Test Kit cleared by the FDA?
Thyroglobulin Eia Test Kit (K951362) received a 510(k) decision of Substantially Equivalent on November 20, 1995, 241 days after the submission was received.
What is the product code of K951362?
The FDA product code is JNL – Immunochemical, Thyroglobulin Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.