510(k) K082150 ยท NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
| Applicant | Preanalytix GmbH, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Jul 30, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082150
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.