510(k) K092566 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Aug 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092566
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.