FDA 510(k) Applications for Medical Device Product Code: JNL (Immunochemical, Thyroglobulin Autoantibody)

FDA 510(k) Applications for Medical Device Product Code "JNL"
(Immunochemical, Thyroglobulin Autoantibody)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K112933	BECKMAN COULTER, INC.	ACCESS THYROGLOBULIN ANITBODY	12/27/2011
K062516	BECKMAN COULTER, INC.	ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)	10/05/2006
K962341	HYCOR BIOMEDICAL, INC.	HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)	11/25/1996
K962451	HYCOR BIOMEDICAL, INC.	HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)	11/25/1996
K971834	MONOBIND	ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA	07/03/1997
K072661	PHADIA US INC.	IMMUNOCAP THYRLOBULIN IMMUNOCAP	11/20/2007