510(k) K082150
- Device
- MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
- Applicant
- PREANALYTIX GMBH
- 510(k) number
- K082150
- Product code
- NTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-04
- Date received
- 2008-07-30
- Regulation
- 866.4070
- Classification name
- System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test
- Medical specialty
- Immunology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WENDY BALLESTEROS
- Address
- 1 Becton Dr. Mc 300 Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3005202328
- 3013055489
- 3013557562
- 3004013603
- 9617032
Source Documents#
Other 510(k) Records For Product Code NTW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN050003 | PAXGENE BLOOD RNA SYSTEM | Preanalytix GmbH | 2005-04-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary