Atlas FDA

JNL

22 FDA 510(k) clearances · Product code

83 daysmedian time to decision
241 days90th percentile
22clearances measured

FDA profile

Official device name
Immunochemical, Thyroglobulin Autoantibody
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5870
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816)Siemens Healthcare Diagnostics, Inc.2025-12-04
Access Thyroglobulin Antibody II (K240996)Beckman Coulter, Inc.2024-07-03
ACCESS THYROGLOBULIN ANITBODY (K112933)Beckman Coulter, Inc.2011-12-27
IMMUNOCAP THYRLOBULIN IMMUNOCAP (K072661)Phadia US, Inc.2007-11-20
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516)Beckman Coulter, Inc.2006-10-05
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (K971834)Monobind1997-07-03
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (K962451)Hycor Biomedical, Inc.1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (K962341)Hycor Biomedical, Inc.1996-11-25
ANTI-TPO (K954256)Biomerica, Inc.1995-11-27
THYROGLOBULIN EIA TEST KIT (K951362)Immunoprobe, Inc.1995-11-20
MICROSOMAL EIA TEST KIT (K951364)Immunoprobe, Inc.1995-11-20
AURAFLEX TG-AB AND TPO-AB (K951320)Organon Teknika Corp.1995-08-25
AURAFLEX TPO-AB (K952607)Organon Teknika Corp.1995-08-25
AUTOSTAT II ANTI-TPO (K943580)Cogent Diagnotics , Ltd.1995-04-17
MICROSOMAL EIA TEST KIT (K941361)Immunoprobe, Inc.1994-05-11
THYROGLOBULIN EIA TEST KIT (K941358)Immunoprobe, Inc.1994-05-11
THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT (K930777)Nichols Institute1993-04-08
AUTOSTAT ANTI-THYROID MICROSSOMAL (K923371)Cogent Diagnotics , Ltd.1992-09-22
AUTOSTAT ANTI-THYROGLOBULIN (K923370)Cogent Diagnotics , Ltd.1992-09-22
SYNELISA TPO ANTIBODIES (K921787)Elias U.S.A., Inc.1992-07-28
IMMUNOWELL TPO (MICROSOME) TEST (K905486)General Biometrics, Inc.1991-01-03
IMMUNODOT THYROID AUTOIMMUNITY PANEL (K903843)General Biometrics, Inc.1990-10-02

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Every clearance here is in the API, with alerts when new ones post.