K082150 is an FDA 510(k) clearance for the MODIFICATION TO 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 Cleared decision on February 4, 2009, 189 days after receiving the submission on July 30, 2008.
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 | K082150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2008 |
| Decision Date | February 04, 2009 |
| Days to Decision | 189 days |
| Submission Type | Special |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| 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 |