510(k) K083088 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Oct 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083088
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.