Cleared Traditional

DUOPATH VEROTOXINS GLISA TEST

K031367 · Emd Chemicals, Inc. · Microbiology
Jan 2004
Decision
268d
Days
Class 1
Risk

About This 510(k) Submission

K031367 is an FDA 510(k) clearance for the DUOPATH VEROTOXINS GLISA TEST, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 23, 2004, 268 days after receiving the submission on April 30, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K031367 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2003
Decision Date January 23, 2004
Days to Decision 268 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GNA — Antisera, All Types, Escherichia Coli
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3255