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 |