ClearanceBrief
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)
Get daily alerts for JNLSample briefCSV

Top companies in JNL

Company510(k)sRecalls
Beckman Coulter, Inc.34
Immunoprobe, Inc.40
Cogent Diagnotics , Ltd.30
General Biometrics, Inc.20
Hycor Biomedical, Inc.20
Organon Teknika Corp.20
Biomerica, Inc.10
Elias U.S.A., Inc.10
Monobind10
Nichols Institute10
DateFirm and productCodeLinked 510(k)
Oct 30, 2024Beckman Coulter, Inc.
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determ
Open, Classified		 JNLK112933
Jun 2, 2020Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 6
Terminated		 JNLK112933
Mar 24, 2011Beckman Coulter Inc.
Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human se
Terminated		 JNLK062516
Sep 2, 2010Beckman Coulter Inc.
Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin an
Terminated		 JNLK062516

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.