Cleared Traditional

PREMIER EHEC

K953362 · Meridian Diagnostics, Inc. · Microbiology
Nov 1995
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K953362 is an FDA 510(k) clearance for the PREMIER EHEC, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 14, 1995, 120 days after receiving the submission on July 17, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K953362 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1995
Decision Date November 14, 1995
Days to Decision 120 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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