CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II

Antigen, Cf (including Cf Control), Cytomegalovirus

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Cytomegalovirus Antibody Fluoro-kit Ii.

Pre-market Notification Details

Device IDK833089
510k NumberK833089
Device Name:CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
ClassificationAntigen, Cf (including Cf Control), Cytomegalovirus
Applicant CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGQH  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-12
Decision Date1984-05-02

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