Cleared Traditional

IMMUNOCARD STAT! E. COLI O157:H7

K990263 · Meridian Diagnostics, Inc. · Microbiology
Aug 1999
Decision
194d
Days
Class 1
Risk

About This 510(k) Submission

K990263 is an FDA 510(k) clearance for the IMMUNOCARD STAT! E. COLI O157:H7, a Antigens, All Types, Escherichia Coli (Class I — General Controls, product code GMZ), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 9, 1999, 194 days after receiving the submission on January 27, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K990263 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1999
Decision Date August 09, 1999
Days to Decision 194 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

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