True Diagnostics, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K182328VeriClear Digital Early Result Pregnancy TestMay 15, 2019
K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (CDecember 22, 2017