Cleared Traditional

K023599 - IMMUNOCARD STAT! E. COLI O157 PLUS (FDA 510(k) Clearance)

K023599 · Meridian Bioscience, Inc. · Microbiology device

Jan 2003

Decision

67d

Days

Class 1

Risk

K023599 is an FDA 510(k) clearance for the IMMUNOCARD STAT! E. COLI O157 PLUS. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number	K023599 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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