FDA.reportPublic FDA data

TRUE DIAGNOSTICS, INC.

Matched from indexed company URL: True Diagnostics, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30275004523027500452TRUE DIAGNOSTICS, INC.1N2026-01-015919 Farnsworth Ct Carlsbad CA US 92008
30128577493012857749TRUE DIAGNOSTICS, INC.1N2020-04-252782 Loker Ave West Carlsbad CA US 92010

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2214001749075651K172257TrueDX 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)JHI2017-12-22
3208341749075651K172257TrueDX 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)JHI2017-12-22
2214001262279162
3208341286173114
3208341600379134
3208341703953192
3208341757838468

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JHI22017-12-22

PMN#