Cleared Traditional

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION

K904400 · Meridian Diagnostics, Inc. · Microbiology
Oct 1990
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K904400 is an FDA 510(k) clearance for the MERIFLUOR TM PNEUMOCYSTIS MODIFICATION, a Pneumocystis Carinii (Class II — Special Controls, product code LYF), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 16, 1990, 25 days after receiving the submission on September 21, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K904400 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1990
Decision Date October 16, 1990
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LYF — Pneumocystis Carinii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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