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Preanalytix GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K231469PAXgene® Blood DNA TubeJune 21, 2023
K142821PAXgene Blood DNA TubeSeptember 9, 2015
K082150MODIFICATION TO PAXGENE BLOOD RNA SYSTEMFebruary 4, 2009
DEN050003PAXGENE BLOOD RNA SYSTEMApril 18, 2005