MODIFICATION TO PAXGENE BLOOD RNA SYSTEM— 510(k) K082150
Substantially EquivalentPreanalytix GmbH
FDA 510(k) clearance K082150 for MODIFICATION TO PAXGENE BLOOD RNA SYSTEM, Substantially Equivalent on 2009-02-04. Applicant: Preanalytix GmbH.
Clearance details
- Applicant
- Preanalytix GmbH
- Product code
- Code NTW
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Franklin Lakes, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.