DEN050003 is an FDA 510(k) submission for the PAXGENE BLOOD RNA SYSTEM. This device is classified as a System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test (Class II - Special Controls, product code NTW).
Submitted by Preanalytix GmbH (Franklin Lakes, US). The FDA issued a Not Cleared (DENG) decision on April 18, 2005.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.4070. System For Collection, Storage, And Transport Of Whole Blood And Stabilization Of Intracellular Rna With Subsequent Isolation And Purification Of Host Rna For Rt-pcr Used In Molecular Diagnostic Testing.
| 510(k) Number | DEN050003 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 28, 2005 |
| Decision Date | April 18, 2005 |
| Days to Decision | 49 days |
| Submission Type | Post-NSE |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | NTW - System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.4070 |
| Definition | System For Collection, Storage, And Transport Of Whole Blood And Stabilization Of Intracellular Rna With Subsequent Isolation And Purification Of Host Rna For Rt-pcr Used In Molecular Diagnostic Testing |