FDA.reportPublic FDA data

510(k) K240996

Device
Access Thyroglobulin Antibody II
Applicant
Beckman Coulter, Inc.
510(k) number
K240996
Product code
JNL
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-03
Date received
2024-04-11
Regulation
866.5870
Classification name
Immunochemical, Thyroglobulin Autoantibody
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kate Oelberg
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JNL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.2025-12-04
K112933ACCESS THYROGLOBULIN ANITBODYBeckman Coulter, Inc.2011-12-27
K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPPhadia US, Inc.2007-11-20
K062516ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)Beckman Coulter, Inc.2006-10-05
K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobind1997-07-03
K962341HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)Hycor Biomedical, Inc.1996-11-25
K962451HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)Hycor Biomedical, Inc.1996-11-25
K954256ANTI-TPOBiomerica, Inc.1995-11-27
K951362THYROGLOBULIN EIA TEST KITImmunoprobe, Inc.1995-11-20
K951364MICROSOMAL EIA TEST KITImmunoprobe, Inc.1995-11-20
K951320AURAFLEX TG-AB AND TPO-ABOrganon Teknika Corp.1995-08-25
K952607AURAFLEX TPO-ABOrganon Teknika Corp.1995-08-25
K943580AUTOSTAT II ANTI-TPOCogent Diagnotics , Ltd.1995-04-17
K941358THYROGLOBULIN EIA TEST KITImmunoprobe, Inc.1994-05-11
K941361MICROSOMAL EIA TEST KITImmunoprobe, Inc.1994-05-11