Cleared Traditional

PREMIER PLATINUM HPSA

K980076 · Meridian Diagnostics, Inc. · Microbiology
May 1998
Decision
124d
Days
Class 1
Risk

About This 510(k) Submission

K980076 is an FDA 510(k) clearance for the PREMIER PLATINUM HPSA, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 12, 1998, 124 days after receiving the submission on January 8, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K980076 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 1998
Decision Date May 12, 1998
Days to Decision 124 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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