FDA Product Code JNL: Immunochemical, Thyroglobulin Autoantibody
Leading manufacturers include Beckman Coulter, Inc., Organon Teknika Corp. and Hycor Biomedical, Inc..
22
Total
22
Cleared
111d
Avg days
1990
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
261d
recently vs 104d historically
FDA 510(k) Cleared Immunochemical, Thyroglobulin Autoantibody Devices (Product Code JNL)
22 devices
Cleared
Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
Siemens Healthcare Diagnostics, Inc.
Immunology
261d
Cleared
Jul 03, 2024
Access Thyroglobulin Antibody II
Beckman Coulter, Inc.
Immunology
83d
Cleared
Dec 27, 2011
ACCESS THYROGLOBULIN ANITBODY
Beckman Coulter, Inc.
Immunology
85d
Cleared
Oct 05, 2006
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
Beckman Coulter, Inc.
Immunology
38d
Cleared
Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
Hycor Biomedical, Inc.
Immunology
160d
Cleared
Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
Hycor Biomedical, Inc.
Immunology
160d
Cleared
Aug 25, 1995
AURAFLEX TG-AB AND TPO-AB
Organon Teknika Corp.
Immunology
155d
Cleared
Aug 25, 1995
AURAFLEX TPO-AB
Organon Teknika Corp.
Immunology
86d
Cleared
Jul 28, 1992
SYNELISA TPO ANTIBODIES
Elias U.S.A., Inc.
Immunology
105d
About Product Code JNL - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code JNL since 1990, with 22 receiving FDA clearance (average review time: 111 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - JNL Product Code
Recent submissions under JNL have taken an average of 261 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.
JNL devices are reviewed by the Immunology panel. Browse all Immunology devices →