MERIFLUOR(TM) PNEUMOCYSTIS

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.

Pre-market Notification Details

Device IDK881608
510k NumberK881608
Device Name:MERIFLUOR(TM) PNEUMOCYSTIS
ClassificationPneumocystis Carinii
Applicant MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactBruce A Clinton,phd
CorrespondentBruce A Clinton,phd
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 Received1988-04-12
Decision Date1988-08-04

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