510(k) K103209 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Jan 10, 2011 |
| Received | Nov 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory viru Terminated |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.