510(k) K070597 ยท NSU Instrumentation For Clinical Multiplex Test Systems
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Oct 11, 2007 |
| Received | Mar 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070597
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.