Cleared Traditional

MERIFLUOR(TM) PNEUMOCYSTIS

K881608 · Meridian Diagnostics, Inc. · Microbiology
Aug 1988
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K881608 is an FDA 510(k) clearance for the MERIFLUOR(TM) PNEUMOCYSTIS, a Pneumocystis Carinii (Class II — Special Controls, product code LYF), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 4, 1988, 114 days after receiving the submission on April 12, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K881608 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1988
Decision Date August 04, 1988
Days to Decision 114 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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