Medical Device Manufacturer · US , Dallas , TX

Immuno Concepts, N.A. , Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

Recent clearances: Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System, Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Immuno Concepts, N.A. , Ltd. Immunology ✕

4 devices

1-4 of 4

Cleared May 26, 2023

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent...

Immunology · 898d

Cleared Oct 19, 2018

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by...

Immunology · 268d

Cleared Jun 17, 2016

Image Navigator by Immuno Concepts

Immunology · 136d

Cleared May 12, 2003

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

Immunology · 62d