Cleared Traditional

IMMUNOCARD H. PYLORI

K961508 · Meridian Diagnostics, Inc. · Microbiology
Jan 1997
Decision
277d
Days
Class 1
Risk

About This 510(k) Submission

K961508 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 January 21, 1997, 277 days after receiving the submission on April 19, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K961508 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1996
Decision Date January 21, 1997
Days to Decision 277 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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