True Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for True Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

True Diagnostics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Jerry Lee
• Kevin Wang

FDA Registration(s)

• Registration Number: 3012857749
• FEI Number: 3012857749
• Name: TRUE DIAGNOSTICS, INC.
• Owner & Operator: True Diagnostics, Inc.
• Contact Address: 2782 Loker Ave West ; Carlsbad CA 92010 US
• Official Correspondent:
  • Jerry Lee
  • x-760-6839158-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2782 Loker Ave West ; Carlsbad, CA 92010 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K182328 True Diagnostics, Inc.	VeriClear Digital Early Result Pregnancy Test	2019-05-15
PMN K172257 True Diagnostics, Inc	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)	2017-12-22