Cleared Traditional

MODIFICATION TO: PREMIER PLATINUM HPSA

K983255 · Meridian Diagnostics, Inc. · Microbiology
Dec 1998
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K983255 is an FDA 510(k) clearance for the MODIFICATION TO: 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 December 17, 1998, 93 days after receiving the submission on September 15, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K983255 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1998
Decision Date December 17, 1998
Days to Decision 93 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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