ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K-Number: K191184 · 2020-03-05
ApplicantSsi Diagnostica A/S
Decision Date2020-03-05
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is a medical device manufactured by Ssi Diagnostica A/S. It received FDA 510(k) clearance on 2020-03-05 under approval number K191184. The device is classified under product code MJH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is a medical device that received FDA 510(k) clearance on 2020-03-05. It is manufactured by Ssi Diagnostica A/S. The 510(k) number is K191184.
When was ImmuView S pneumoniae and L pneumophila Urinary Antigen Test approved by the FDA?
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test received FDA 510(k) clearance on 2020-03-05, under approval number K191184.
What company makes ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is manufactured by Ssi Diagnostica A/S.
What is the FDA product code for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?
The FDA product code for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is MJH.
Related Devices (Code: MJH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.