Cleared Traditional

RELISA ENA ANTIBODY SCREENING TEST SYSTEM

K935129 · Immuno Concepts, Inc. · Immunology
Jan 1994
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K935129 is an FDA 510(k) clearance for the RELISA ENA ANTIBODY SCREENING TEST SYSTEM, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on January 31, 1994, 95 days after receiving the submission on October 28, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K935129 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1993
Decision Date January 31, 1994
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LLL Extractable Antinuclear Antibody, Antigen And Control

All 179
Alegria Flash CTD Screen
K250666 · Zeus Scientific · Oct 2025
Alegria Flash ENA Screen
K250408 · Zeus Scientific · Sep 2025
Aptiva CTD Essential Reagent
K213403 · Inova Diagnostics, Inc. · Sep 2023
EliA SymphonyS Immunoassay
K190710 · Phadia AB · Nov 2019
QUANTA Flash HMGCR Reagents
K180975 · Inova Diagnostics, Inc. · Jun 2018
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
K152635 · Inova Diagnostics, Inc. · Jun 2016