Cleared Traditional

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

K191184 · Ssi Diagnostica A/S · Microbiology

Mar 2020

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K191184 is an FDA 510(k) clearance for the ImmuView S pneumoniae and L pneumophila Urinary Antigen Test, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Ssi Diagnostica A/S (Hilleroed, DK). The FDA issued a Cleared decision on March 5, 2020, 307 days after receiving the submission on May 3, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K191184 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2019
Decision Date	March 05, 2020
Days to Decision	307 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF