Cleared Traditional

VARELISA DSDNA ANTIBODIES (FARR VERSION)

K950031 · Elias U.S.A., Inc. · Immunology
Mar 1995
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K950031 is an FDA 510(k) clearance for the VARELISA DSDNA ANTIBODIES (FARR VERSION), a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on March 10, 1995, 65 days after receiving the submission on January 4, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K950031 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1995
Decision Date March 10, 1995
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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