Cleared Traditional

DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM

K994424 · Diamedix Corp. · Immunology
Feb 2000
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K994424 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on February 18, 2000, 50 days after receiving the submission on December 30, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K994424 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1999
Decision Date February 18, 2000
Days to Decision 50 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 28
IMMULISA DSDNA ANTIBODY ELISA
K101319 · Immco Diagnostics, Inc. · Dec 2010
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
K083381 · Euroimmun Us, Inc. · Apr 2009
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
K062183 · The Binding Site, Ltd. · Nov 2006
VARELISA SSDNA ANTIBODIES, MODEL 14896
K040811 · Pharmacia Deutschland GmbH · May 2004
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
K001900 · Helix Diagnostics, Inc. · Sep 2000
MDI DS-DNA TEST
K000477 · Micro Detect, Inc. · Mar 2000