...If the de novo is declined, the device remains in class III and may not be marketed.
https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM273903.pdf
page 5 section 3
- Forums
- ASX - By Stock
- RAP
- Ann: RAP Licenses Additional Pneumonia Diagnostic from UniQuest
Ann: RAP Licenses Additional Pneumonia Diagnostic from UniQuest, page-159
-
-
- There are more pages in this discussion • 48 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add RAP (ASX) to my watchlist
(20min delay)
|
|||||
Last
20.5¢ |
Change
0.000(0.00%) |
Mkt cap ! $176.2M |
Open | High | Low | Value | Volume |
0.0¢ | 0.0¢ | 0.0¢ | $0 | 0 |
Featured News
STX
Strike hands $48.5M contract to Clarke Energy to produce 20x 4.5MW gas engines for Sth Erregulla
GML
Gateway Mining sells WA Eastern Montague gold project to Brightstar for $14M – half of that in shares
KAI
Pilbara Minerals buys land off Kairos part of its York gold project for $20M – and a 2% royalty on any PLS gold sales
RAP (ASX) Chart |
Day chart unavailable