Cleared Traditional

PREMIER(TM) H. PYLORY

K945558 · Meridian Diagnostics, Inc. · Microbiology
Mar 1995
Decision
109d
Days
Class 1
Risk

About This 510(k) Submission

K945558 is an FDA 510(k) clearance for the PREMIER(TM) H. PYLORY, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 3, 1995, 109 days after receiving the submission on November 14, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K945558 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1994
Decision Date March 03, 1995
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LYR — Helicobacter Pylori
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110

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