ImmuView S Pneumoniae And L Pneumophila Urinary Antigen Test

Legionella, Spp., Elisa

SSI Diagnostica A/S

The following data is part of a premarket notification filed by Ssi Diagnostica A/s with the FDA for Immuview S Pneumoniae And L Pneumophila Urinary Antigen Test.

Pre-market Notification Details

Device IDK191184
510k NumberK191184
Device Name:ImmuView S Pneumoniae And L Pneumophila Urinary Antigen Test
ClassificationLegionella, Spp., Elisa
Applicant SSI Diagnostica A/S 2 Herredsvejen Hilleroed,  DK 3400
ContactPernille Landsbo Elverdal
CorrespondentChristopher Bentsen
Bentsen Regulatory And Clinicals Consulting LLC 25803 NE 9th Street Redmond,  WA  98074
Product CodeMJH  
CFR Regulation Number866.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-03
Decision Date2020-03-05

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