FDA Product Code
FDA Product Code JNL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5870
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 | Traditional | PDF ↗ |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024-07-03 | Traditional | PDF ↗ |
| K112933 | ACCESS THYROGLOBULIN ANITBODY | Beckman Coulter, Inc. | 2011-12-27 | Special | PDF ↗ |
| K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP | Phadia US, Inc. | 2007-11-20 | Special | PDF ↗ |
| K062516 | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) | Beckman Coulter, Inc. | 2006-10-05 | Special | PDF ↗ |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | Monobind | 1997-07-03 | Traditional | PDF ↗ |
| K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | Hycor Biomedical, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | Hycor Biomedical, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K954256 | ANTI-TPO | Biomerica, Inc. | 1995-11-27 | Traditional | PDF ↗ |
| K951364 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 | Traditional | PDF ↗ |
| K951362 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 | Traditional | PDF ↗ |
| K952607 | AURAFLEX TPO-AB | Organon Teknika Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K951320 | AURAFLEX TG-AB AND TPO-AB | Organon Teknika Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K943580 | AUTOSTAT II ANTI-TPO | Cogent Diagnotics , Ltd. | 1995-04-17 | Traditional | PDF ↗ |
| K941361 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | 1994-05-11 | Traditional | PDF ↗ |
| K941358 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1994-05-11 | Traditional | PDF ↗ |
| K930777 | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT | Nichols Institute | 1993-04-08 | Traditional | PDF ↗ |
| K923370 | AUTOSTAT ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1992-09-22 | Traditional | PDF ↗ |
| K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL | Cogent Diagnotics , Ltd. | 1992-09-22 | Traditional | PDF ↗ |
| K921787 | SYNELISA TPO ANTIBODIES | Elias U.S.A., Inc. | 1992-07-28 | Traditional | PDF ↗ |
| K905486 | IMMUNOWELL TPO (MICROSOME) TEST | General Biometrics, Inc. | 1991-01-03 | Traditional | PDF ↗ |
| K903843 | IMMUNODOT THYROID AUTOIMMUNITY PANEL | General Biometrics, Inc. | 1990-10-02 | Traditional | PDF ↗ |
Product code JNL · Class II · Immunology. Data: openFDA.