ImmuView S pneumoniae and L pneumophila Urinary Antigen Test— 510(k) K191184
Substantially EquivalentSsi 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.
Clearance details
- Applicant
- Ssi Diagnostica A/S
- Product code
- Code MJH
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilleroed, DK
Data sourced from openFDA. This site is unofficial and independent of the FDA.