ImmuView S pneumoniae and L pneumophila Urinary Antigen Test— 510(k) K191184

Name: FDA 510(k) clearance K191184
Creator: U.S. Food and Drug Administration
Published: 2020-03-05

Substantially Equivalent

Ssi Diagnostica A/S

FDA 510(k) clearance K191184 for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test, Substantially Equivalent on 2020-03-05. Applicant: Ssi Diagnostica A/S. Device class: 2.

Clearance details

Applicant: Ssi Diagnostica A/S
Product code: Code MJH
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 2019-05-03
Decision date: 2020-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilleroed, DK

Download summary PDF View on FDA.gov ↗

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