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.
| Device ID | K191184 |
| 510k Number | K191184 |
| Device Name: | ImmuView S Pneumoniae And L Pneumophila Urinary Antigen Test |
| Classification | Legionella, Spp., Elisa |
| Applicant | SSI Diagnostica A/S 2 Herredsvejen Hilleroed, DK 3400 |
| Contact | Pernille Landsbo Elverdal |
| Correspondent | Christopher Bentsen Bentsen Regulatory And Clinicals Consulting LLC 25803 NE 9th Street Redmond, WA 98074 |
| Product Code | MJH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2020-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713106024515 | K191184 | 000 |