Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020139194

FEI Number

3020139194

Entity Name

LetsGetChecked Inc.

City/State/Country

Cucamonga, CA, US

Establishment Address

10825 7th Street, Suite A, Cucamonga, CA 91730, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

LetsGetChecked Inc. (Owner Number: 10056783)

Owner / Operator Contact Address

PrivaPath Diagnostics Ltd t/a Lets Get Checked 3rd Floor, Block 1, West Pier Business Campus,, Dun Laoghaire Co.Dublin A96 F8C0, Dublin, IE-D A96 F8C0, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LetsGetChecked Vaginal Sample Collection Kit LetsGetChecked Blood Sample Collection Kit LetsGetChecked Blood and Saliva Collection Kit LetsGetChecked Urine Sample Collection Kit Simple 2 Test LetsGetChecked Multisite Sample Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MXB	Test, Vaginal, Bacterial Sialidase	Microbiology	Class 1	866.2660	2019-03-22
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2018-01-23
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2019-03-06
QYA	System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home	Microbiology	Class 2	866.3385	2024-11-29
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2025-05-23

Official Correspondent

Karen Walsh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LetsGetChecked Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042854290	LetsGetChecked Inc	City View Heights, OH, US
3015209536	Privapath Diagnostics Ltd	Dublin 11, IE

Similar Registrations

Registration Number	Establishment Name	Location
2029372	Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, US
3015209536	Privapath Diagnostics Ltd	Dublin 11, IE
2030538	Sekisui Diagnostics, LLC	SAN DIEGO, CA, US
3006546675	GRYPHUS DIAGNOSTICS, L.L.C.	KNOXVILLE, TN, US
3019792804	MHC HEALTH MANAGEMENT SOLUTIONS, LLC	Cape Coral, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020139194. Last updated year: 2026. Please use registration number 3020139194 when referencing this establishment in official correspondence.