Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

Respiratory Virus Panel Nucleic Acid Assay System

DiaSorin Molecular LLC

The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Flu A/b & Rsv Direct Gen Ii, Simplexa Flu A/b & Rsv Positive Control Pack.

Pre-market Notification Details

Device IDK201505
510k NumberK201505
Device Name:Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
ClassificationRespiratory Virus Panel Nucleic Acid Assay System
Applicant DiaSorin Molecular LLC 11331 Valley View Street Cypress,  CA  90630
ContactSharon Young
CorrespondentSharon Young
DiaSorin Molecular LLC 11331 Valley View Street Cypress,  CA  90630
Product CodeOCC  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-05
Decision Date2020-08-22

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