Access Thyroglobulin Anitbody
FDA 510(k) K112933 · Beckman Coulter, Inc.
510(k) numberK112933
Submission
- Device name
- Access Thyroglobulin Anitbody
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- October 3, 2011
- Decision date
- December 27, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K951362 | Thyroglobulin Eia Test KitJNL · Traditional | Immunoprobe, Inc. | 11/20/1995SE |
More from Immunoprobe, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access Thyroglobulin Anitbody cleared by the FDA?
Access Thyroglobulin Anitbody (K112933) received a 510(k) decision of Substantially Equivalent on December 27, 2011, 85 days after the submission was received.
What is the product code of K112933?
The FDA product code is JNL – Immunochemical, Thyroglobulin Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.