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JNL — Immunochemical, Thyroglobulin Autoantibody Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K250816siemens healthcare diagnosticsADVIA Centaur Anti-Thyroglobulin II (aTgII)December 4, 2025
K240996beckman coulterAccess Thyroglobulin Antibody IIJuly 3, 2024
K112933beckman coulterACCESS THYROGLOBULIN ANITBODYDecember 27, 2011
K072661phadia usIMMUNOCAP THYRLOBULIN IMMUNOCAPNovember 20, 2007
K062516beckman coulterACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIOctober 5, 2006
K971834monobindANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJuly 3, 1997
K962341hycor biomedicalHY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)November 25, 1996
K962451hycor biomedicalHY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)November 25, 1996
K954256biomericaANTI-TPONovember 27, 1995
K951364immunoprobeMICROSOMAL EIA TEST KITNovember 20, 1995
K951362immunoprobeTHYROGLOBULIN EIA TEST KITNovember 20, 1995
K952607organon teknikaAURAFLEX TPO-ABAugust 25, 1995
K951320organon teknikaAURAFLEX TG-AB AND TPO-ABAugust 25, 1995
K943580cogent diagnoticsAUTOSTAT II ANTI-TPOApril 17, 1995
K941358immunoprobeTHYROGLOBULIN EIA TEST KITMay 11, 1994
K941361immunoprobeMICROSOMAL EIA TEST KITMay 11, 1994
K930777nichols instituteTHYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KITApril 8, 1993
K923370cogent diagnoticsAUTOSTAT ANTI-THYROGLOBULINSeptember 22, 1992
K923371cogent diagnoticsAUTOSTAT ANTI-THYROID MICROSSOMALSeptember 22, 1992
K921787elias u.s.aSYNELISA TPO ANTIBODIESJuly 28, 1992