Device Listing 1173237996
Listing Summary#
- Listing key
- 1173237996
- Premarket submission
- K172257
- Device
- TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
- Applicant
- True Diagnostics, Inc.
- Product code
- JHI
- Decision date
- 2017-12-22