Cleared Traditional

PREMIER GIARDIA

K982711 · Meridian Diagnostics, Inc. · Microbiology
Nov 1998
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K982711 is an FDA 510(k) clearance for the PREMIER GIARDIA, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 25, 1998, 113 days after receiving the submission on August 4, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K982711 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1998
Decision Date November 25, 1998
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MHI — Giardia Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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