510(k) DEN050003
- Device
- PAXGENE BLOOD RNA SYSTEM
- Applicant
- Preanalytix GmbH
- 510(k) number
- DEN050003
- Product code
- NTW
- Decision
- Unknown (DENG)
- Decision date
- 2005-04-18
- Date received
- 2005-02-28
- Regulation
- 866.4070
- Classification name
- System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- JING ZHANG
- Address
- 1 Becton Dr. Mc 300 Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3005202328
- 3013055489
- 3013557562
- 3004013603
- 9617032
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NTW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082150 | MODIFICATION TO PAXGENE BLOOD RNA SYSTEM | Preanalytix GmbH | 2009-02-04 |