Caredx, Inc.

FDA Regulatory Profile

Caredx, Inc. appears in FDA public data with 0 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Mar 28, 2017 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Sep 13, 2023.

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Summary

Total Recalls
0
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 28, 2017Brisbane, CADevicesNo Action Indicated (NAI)3005225997
May 16, 2014Brisbane, CADevicesNo Action Indicated (NAI)3005225997

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K221640AlloMap Heart Molecular Expression TestingSep 13, 2023