Cleared Traditional

IMMUNOCARD H. PYLORI

K941560 · Meridian Diagnostics, Inc. · Microbiology
Dec 1994
Decision
251d
Days
Class 1
Risk

About This 510(k) Submission

K941560 is an FDA 510(k) clearance for the IMMUNOCARD H. PYLORI, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 8, 1994, 251 days after receiving the submission on April 1, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K941560 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1994
Decision Date December 08, 1994
Days to Decision 251 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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