Data / Medical devices / United States / True Diagnostics, Inc.
True Diagnostics, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
True Diagnostics, Inc. is registered with the FDA (registration 3027500452) in Carlsbad, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027500452
- Address
- 5919 Farnsworth Ct, Carlsbad, CA, United States, 92008
- Owner or operator
- True Diagnostics, Inc. (10058307)
- Roles
- Contract manufacturer, Manufacturer for export, Specification developer
- First device listed
- August 20, 2018
- Registered through
- 2026
- Brand names listed
- CVS Health Digital Ovulation Test, VeriClear
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | N | Contract manufacturer, Manufacturer for export | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Contract manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2017 | K172257 | 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) | JHI | Substantially Equivalent | True Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Coronavirus Antigen Detection Test System.
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Syringe, Piston
Updated December 22, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.