Anti-Tpo
FDA 510(k) K954256 · Biomerica, Inc.
510(k) numberK954256
Submission
- Device name
- Anti-Tpo
- Applicant
- Biomerica, Inc.
Newport Beach, CA, US - Received
- September 5, 1995
- Decision date
- November 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JNL – Immunochemical, Thyroglobulin Autoantibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5870
- Specialty
- Immunology
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|---|---|---|---|
| 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 |
| K951364 | Microsomal Eia Test KitJNL · Traditional | Immunoprobe, Inc. | 11/20/1995SE |
| K951362 | Thyroglobulin Eia Test KitJNL · Traditional | Immunoprobe, Inc. | 11/20/1995SE |
More from Immunoprobe, Inc.
| 510(k) | Device | Decision |
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| K232892 | Hp Detect Stool Antigen ELISALYR · Traditional | 12/15/2023SE |
| K003856 | Ez-Hcg Urine(Pregnancy Test)JHI · Traditional | 02/21/2001SE |
| K982954 | Free T4 Microwell Eia, Model #7019CEC · Traditional | 09/24/1998SE |
| K962216 | TSH (Microwell) ElisaJLW · Traditional | 09/19/1996SE |
| K960412 | T-3 Microwell Eia Model 7013CDP · Traditional | 03/19/1996SE |
| K950588 | T4 Microwell Eia (Enzyme IMMUNOASSAY0KLI · Traditional | 06/29/1995SE |
| K936010 | Thyroglobulin Autoantibody Enzyme ImmunoassayDDC · Traditional | 07/18/1994SE |
| K915185 | Gap Igg H.Pylori ModifiedLYR · Traditional | 03/04/1992SE |
| K900343 | Gap-IggLYR · Traditional | 08/22/1991SE |
Questions and answers
When was Anti-Tpo cleared by the FDA?
Anti-Tpo (K954256) received a 510(k) decision of Substantially Equivalent on November 27, 1995, 83 days after the submission was received.
What is the product code of K954256?
The FDA product code is JNL – Immunochemical, Thyroglobulin Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.