Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

Bordetella Pertussis Dna Assay System

DiaSorin Molecular LLC

The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack.

Pre-market Notification Details

Device IDK173498
510k NumberK173498
Device Name:Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
ClassificationBordetella Pertussis Dna 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 CodeOZZ  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-13
Decision Date2018-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816101025637 K173498 000
20816101025620 K173498 000

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