MERIFLUOR TM PNEUMOCYSTIS MODIFICATION

Pneumocystis Carinii

MERIDIAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Merifluor Tm Pneumocystis Modification.

Pre-market Notification Details

Device IDK904400
510k NumberK904400
Device Name:MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
ClassificationPneumocystis Carinii
Applicant MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactAllen Nickol
CorrespondentAllen Nickol
MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeLYF  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-21
Decision Date1990-10-16

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