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MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

Preanalytix GmbH · Class II · Cleared Feb 4, 2009

K-numberK082150
Device nameMODIFICATION TO PAXGENE BLOOD RNA SYSTEM
ApplicantPreanalytix GmbH
Product codeNTW
Device classClass II
Decision dateFeb 4, 2009
DecisionSubstantially Equivalent
Regulation866.4070
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View the full FDA submission: accessdata.fda.gov

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