CYTOMEGALOVIRUS

Antigen, Cf (including Cf Control), Cytomegalovirus

INSTITUTE VIRION LTD.

The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Cytomegalovirus.

Pre-market Notification Details

Device IDK843657
510k NumberK843657
Device Name:CYTOMEGALOVIRUS
ClassificationAntigen, Cf (including Cf Control), Cytomegalovirus
Applicant INSTITUTE VIRION LTD. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGQH  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-17
Decision Date1985-09-26

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