Panels › Immunology › Product code JNL · Class 2
Immunochemical, Thyroglobulin Autoantibody
Regulation 866.5870
1510(k)s in 12 months (22 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in JNL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 4, 2025 | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) Siemens Healthcare Diagnostics, Inc. | JNL |
| Jul 3, 2024 | K240996 | Access Thyroglobulin Antibody II Beckman Coulter, Inc. | JNL |
| Dec 27, 2011 | K112933 | ACCESS THYROGLOBULIN ANITBODY Beckman Coulter, Inc. | JNL |
| Nov 20, 2007 | K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP Phadia US, Inc. | JNL |
| Oct 5, 2006 | K062516 | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) Beckman Coulter, Inc. | JNL |
| Jul 3, 1997 | K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA Monobind | JNL |
| Nov 25, 1996 | K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) Hycor Biomedical, Inc. | JNL |
| Nov 25, 1996 | K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) Hycor Biomedical, Inc. | JNL |
| Nov 27, 1995 | K954256 | ANTI-TPO Biomerica, Inc. | JNL |
| Nov 20, 1995 | K951364 | MICROSOMAL EIA TEST KIT Immunoprobe, Inc. | JNL |
| Nov 20, 1995 | K951362 | THYROGLOBULIN EIA TEST KIT Immunoprobe, Inc. | JNL |
| Aug 25, 1995 | K952607 | AURAFLEX TPO-AB Organon Teknika Corp. | JNL |
| Aug 25, 1995 | K951320 | AURAFLEX TG-AB AND TPO-AB Organon Teknika Corp. | JNL |
| Apr 17, 1995 | K943580 | AUTOSTAT II ANTI-TPO Cogent Diagnotics , Ltd., GB | JNL |
| May 11, 1994 | K941361 | MICROSOMAL EIA TEST KIT Immunoprobe, Inc. | JNL |
| May 11, 1994 | K941358 | THYROGLOBULIN EIA TEST KIT Immunoprobe, Inc. | JNL |
| Apr 8, 1993 | K930777 | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT Nichols Institute | JNL |
| Sep 22, 1992 | K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL Cogent Diagnotics , Ltd., GB | JNL |
| Sep 22, 1992 | K923370 | AUTOSTAT ANTI-THYROGLOBULIN Cogent Diagnotics , Ltd., GB | JNL |
| Jul 28, 1992 | K921787 | SYNELISA TPO ANTIBODIES Elias U.S.A., Inc. | JNL |
| Jan 3, 1991 | K905486 | IMMUNOWELL TPO (MICROSOME) TEST General Biometrics, Inc. | JNL |
| Oct 2, 1990 | K903843 | IMMUNODOT THYROID AUTOIMMUNITY PANEL General Biometrics, Inc. | JNL |
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