CYTOMEGALOVIRUS CONTROL SLIDES

Antigen, Cf (including Cf Control), Cytomegalovirus

MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Cytomegalovirus Control Slides.

Pre-market Notification Details

Device IDK873114
510k NumberK873114
Device Name:CYTOMEGALOVIRUS CONTROL SLIDES
ClassificationAntigen, Cf (including Cf Control), Cytomegalovirus
Applicant MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta,  GA  30909
ContactDavid A Wall
CorrespondentDavid A Wall
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta,  GA  30909
Product CodeGQH  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-10
Decision Date1987-09-25

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