Cleared Traditional

IMMUNOCARD STAT! EHEC, MODEL 751630

K062546 · Meridian Bioscience, Inc. · Microbiology
Feb 2007
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K062546 is an FDA 510(k) clearance for the IMMUNOCARD STAT! EHEC, MODEL 751630, a Antigens, All Types, Escherichia Coli (Class I — General Controls, product code GMZ), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 14, 2007, 168 days after receiving the submission on August 30, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K062546 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2006
Decision Date February 14, 2007
Days to Decision 168 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

Similar Devices — GMZ Antigens, All Types, Escherichia Coli

All 13
Curian? Shiga Toxin
K222829 · Meridian Bioscience, Inc. · Apr 2023
SHIGA TOXIN QUIK CHEK
K121364 · Techlab Inc., Corporate Research Center · Oct 2012
SHIGA TOXIN CHEK
K121411 · Techlab Inc., Corporate Research Center · Oct 2012
BIOSTAR OIA SHIGATOX
K061889 · Inverness Medical-Biostar, Inc. · Dec 2006
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · Meridian Bioscience, Inc. · Jan 2003
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · Meridian Diagnostics, Inc. · Aug 1999