Immunodot Thyroid Autoimmunity Panel
FDA 510(k) K903843 · General Biometrics, Inc.
510(k) numberK903843
Submission
- Device name
- Immunodot Thyroid Autoimmunity Panel
- Applicant
- General Biometrics, Inc.
San Diego, CA, US - Received
- August 21, 1990
- Decision date
- October 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K924843 | Immunodot(R) Ena/Dna Autoimmunity Screening PanelLLL · Traditional | 12/01/1992SE |
| K920401 | Immunowell Cardiolipin Antibody (Igm) TestMID · Traditional | 08/20/1992SE |
| K920400 | Immunowell Cardiolipin Antibody (Igg) TestMID · Traditional | 08/20/1992SE |
| K911627 | Immunodot Borrelia (Lyme) TestLSR · Traditional | 04/08/1992SE |
| K911599 | Immunowell Lyme (P39 Recombinant) TestLSR · Traditional | 12/30/1991SE |
| K911590 | Immunowell Borrelia (Lyme)TestLSR · Traditional | 12/20/1991SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | 12/09/1991SE |
| K911851 | Immunowell SM Antibody TestLKP · Traditional | 05/07/1991SE |
| K911850 | Immunwell Sjogren`S Syndrome B (la) Antibody TestLKO · Traditional | 05/07/1991SE |
| K911849 | Immunowell Sjogrens Syndrome a (Ro)Antibody TestLKO · Traditional | 05/07/1991SE |
Questions and answers
When was Immunodot Thyroid Autoimmunity Panel cleared by the FDA?
Immunodot Thyroid Autoimmunity Panel (K903843) received a 510(k) decision of Substantially Equivalent on October 2, 1990, 42 days after the submission was received.
What is the product code of K903843?
The FDA product code is JNL – Immunochemical, Thyroglobulin Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.