Data / Medical devices / United States / LetsGetChecked Inc.
LetsGetChecked Inc.: FDA-registered device maker in Cucamonga, CA, United States, 2 510(k) clearances
LetsGetChecked Inc. is registered with the FDA (registration 3020139194) in Cucamonga, CA, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020139194
- Address
- 10825 7th Street, Suite A, Cucamonga, CA, United States, 91730
- Owner or operator
- LetsGetChecked Inc. (10056783)
- Roles
- Complaint file establishment
- First device listed
- January 23, 2018
- Registered through
- 2026
- Brand names listed
- LetsGetChecked Blood Sample Collection Kit, LetsGetChecked Blood and Saliva Collection Kit, LetsGetChecked Blood and Urine Collection Kit, LetsGetChecked Saliva Sample Collection Kit, LetsGetChecked Stool Sample Collection Kit, LetsGetChecked Urine Sample Collection Kit, LetsGetChecked Vaginal Sample Collection Kit, Onclarity Self-Collection Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Complaint file establishment | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Complaint file establishment | accessdata.fda.gov |
| Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | SEP | 2 | Complaint file establishment | accessdata.fda.gov |
| System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home | QYA | 2 | Complaint file establishment | accessdata.fda.gov |
| Test, Vaginal, Bacterial Sialidase | MXB | 1 | Complaint file establishment | accessdata.fda.gov |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| April 2, 2026 | K260184 | Onclarity Self-Collection Kit | SEP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 15, 2023 | DEN200070 | Simple 2 Test | QYA | Unknown | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Vaginal, Bacterial Sialidase
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Urine Collection Kit (Excludes Hiv Testing)
Updated April 2, 2026. 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.