FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

Pneumocystis Carinii

DISEASE DETECTION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Fluoroslide Pneumocystis Carinii (ifa) Assay.

Pre-market Notification Details

Device IDK884047
510k NumberK884047
Device Name:FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
ClassificationPneumocystis Carinii
Applicant DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
ContactEl-badry, Ph.d.
CorrespondentEl-badry, Ph.d.
DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
Product CodeLYF  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-26
Decision Date1989-03-14

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