Immunocap Thyrlobulin Immunocap
FDA 510(k) K072661 · Phadia US, Inc.
510(k) numberK072661
Submission
- Device name
- Immunocap Thyrlobulin Immunocap
- Applicant
- Phadia US, Inc.
Portage, MI, US - Received
- September 21, 2007
- Decision date
- November 20, 2007
- 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
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| K240996 | Access Thyroglobulin Antibody IIJNL · Traditional | Beckman Coulter, Inc. | 07/03/2024SE |
| K112933 | Access Thyroglobulin AnitbodyJNL · Special | Beckman Coulter, Inc. | 12/27/2011SE |
| 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 |
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Questions and answers
When was Immunocap Thyrlobulin Immunocap cleared by the FDA?
Immunocap Thyrlobulin Immunocap (K072661) received a 510(k) decision of Substantially Equivalent on November 20, 2007, 60 days after the submission was received.
What is the product code of K072661?
The FDA product code is JNL – Immunochemical, Thyroglobulin Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.