510(k) DEN050003
DEN050003 is an FDA 510(k) premarket notification submitted by Preanalytix GmbH for the device "PAXGENE BLOOD RNA SYSTEM". The FDA issued a decision of De Novo Granted on April 18, 2005. The device falls under product code NTW (System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test), a Class II device regulated under 21 CFR 866.4070. Preanalytix GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 18, 2005
- Date Received
- February 28, 2005
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
- Device Class
- Class II
- Regulation Number
- 866.4070
- Review Panel
- PA
- Submission Type
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