Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)
FDA 510(k) K062516 · Beckman Coulter, Inc.
510(k) numberK062516
Submission
- Device name
- Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- August 28, 2006
- Decision date
- October 5, 2006
- 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
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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 |
| 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 |
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Questions and answers
When was Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators) cleared by the FDA?
Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators) (K062516) received a 510(k) decision of Substantially Equivalent on October 5, 2006, 38 days after the submission was received.
What is the product code of K062516?
The FDA product code is JNL – Immunochemical, Thyroglobulin Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.