JNL — Immunochemical, Thyroglobulin Autoantibody Class II
FDA product code JNL covers "Immunochemical, Thyroglobulin Autoantibody", a Class II medical device regulated under 21 CFR 866.5870. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JNL
- Device Class
- Class II
- Regulation Number
- 866.5870
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250816 | siemens healthcare diagnostics | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | December 4, 2025 |
| K240996 | beckman coulter | Access Thyroglobulin Antibody II | July 3, 2024 |
| K112933 | beckman coulter | ACCESS THYROGLOBULIN ANITBODY | December 27, 2011 |
| K072661 | phadia us | IMMUNOCAP THYRLOBULIN IMMUNOCAP | November 20, 2007 |
| K062516 | beckman coulter | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALI | October 5, 2006 |
| K971834 | monobind | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | July 3, 1997 |
| K962451 | hycor biomedical | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | November 25, 1996 |
| K962341 | hycor biomedical | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | November 25, 1996 |
| K954256 | biomerica | ANTI-TPO | November 27, 1995 |
| K951362 | immunoprobe | THYROGLOBULIN EIA TEST KIT | November 20, 1995 |
| K951364 | immunoprobe | MICROSOMAL EIA TEST KIT | November 20, 1995 |
| K952607 | organon teknika | AURAFLEX TPO-AB | August 25, 1995 |
| K951320 | organon teknika | AURAFLEX TG-AB AND TPO-AB | August 25, 1995 |
| K943580 | cogent diagnotics | AUTOSTAT II ANTI-TPO | April 17, 1995 |
| K941361 | immunoprobe | MICROSOMAL EIA TEST KIT | May 11, 1994 |
| K941358 | immunoprobe | THYROGLOBULIN EIA TEST KIT | May 11, 1994 |
| K930777 | nichols institute | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT | April 8, 1993 |
| K923370 | cogent diagnotics | AUTOSTAT ANTI-THYROGLOBULIN | September 22, 1992 |
| K923371 | cogent diagnotics | AUTOSTAT ANTI-THYROID MICROSSOMAL | September 22, 1992 |
| K921787 | elias u.s.a | SYNELISA TPO ANTIBODIES | July 28, 1992 |