Cleared Traditional

IMMUNOCARD STAT! E. COLI O157 PLUS

K023599 · Meridian Bioscience, Inc. · Microbiology
Jan 2003
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K023599 is an FDA 510(k) clearance for the IMMUNOCARD STAT! E. COLI O157 PLUS, 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 January 3, 2003, 67 days after receiving the submission on October 28, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K023599 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2002
Decision Date January 03, 2003
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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