Cleared Traditional

MDI SCL-70 TEST

K000934 · Micro Detect, Inc. · Immunology
Apr 2000
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K000934 is an FDA 510(k) clearance for the MDI SCL-70 TEST, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on April 7, 2000, 15 days after receiving the submission on March 23, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K000934 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2000
Decision Date April 07, 2000
Days to Decision 15 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 111
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K182353 · Phadia AB · Nov 2018
ImmuLisa Enhanced Centromere Antibody ELISA
K151559 · Immco Diagnostics, Inc. · Mar 2016
ELIA SCL-70S IMMUNOASSAY
K140493 · Phadia GmbH · Oct 2014
QUANTA FLASH CENTROMERE
K123880 · Inova Diagnostics, Inc. · Feb 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
K131330 · Gold Standard Diagnostics · Jan 2014
ANA SCREEN ELISA (IGG)
K131185 · Euroimmun US · Jul 2013