Cleared Traditional

MICROSPORIDIUM CONTROL SET

K943228 · Meridian Diagnostics, Inc. · Microbiology
Oct 1994
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K943228 is an FDA 510(k) clearance for the MICROSPORIDIUM CONTROL SET, a Quality Control Slides (Class I — General Controls, product code LJG), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 27, 1994, 113 days after receiving the submission on July 6, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K943228 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1994
Decision Date October 27, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJG — Quality Control Slides
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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