Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

FDA 510(k) Premarket Notification · Submission K203599 · Applicant: Immuno Concepts, N.A. , Ltd.

Public Record 510(k) Submission Decision Date: 2023-05-26 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K203599.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K203599

Applicant / Sponsor

Immuno Concepts, N.A. , Ltd.

Device Name

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

Product Code

KTL

Decision Date

2023-05-26

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

2020-12-09

Related Establishments / Registrations

INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
ZEUS SCIENTIFIC LLC Registration: 2242436 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
IMMUNO CONCEPTS, NA, Ltd. Registration: 2918768 View Registration
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG Registration: 3003268355 View Registration
EUROIMMUN US INC. Registration: 3007118747 View Registration
EUROIMMUN Medizinische Labordiagnostika AG Registration: 3007361513 View Registration
VISIA LAB SRL Registration: 3026753391 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.