PAXGENE BLOOD RNA SYSTEM— 510(k) DEN050003

Unknown

Preanalytix GmbH

FDA 510(k) clearance DEN050003 for PAXGENE BLOOD RNA SYSTEM, Unknown on 2005-04-18. Applicant: Preanalytix GmbH. Device class: 2.

Clearance details

Applicant: Preanalytix GmbH
Product code: Code NTW
Device class: Class 2
Regulation: 21 CFR 866.4070
Advisory panel: Immunology
Date received: 2005-02-28
Decision date: 2005-04-18
Decision: Unknown
Clearance type: Post-NSE
Location: Franklin Lakes, NJ, US

View on FDA.gov ↗

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