Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042854290

FEI Number

3042854290

Entity Name

LetsGetChecked Inc

City/State/Country

City View Heights, OH, US

Establishment Address

Suite 300, 8407 Firebird Dr, Fairfield, OH 45011, USA, City View Heights, OH 45011, 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 Blood Sample Collection Kit LetsGetChecked Blood and Saliva Collection Kit LetsGetChecked Stool Sample Collection Kit LetsGetChecked Saliva Sample Collection Kit LetsGetChecked ImPress Simple 2 Test LetsGetChecked Saliva Sample Collection Kit LetsGetChecked Multisite Sample Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2018-01-23
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2019-03-22
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-03-11
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
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2024-05-08
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
3020139194	LetsGetChecked Inc.	Cucamonga, CA, US
3015209536	Privapath Diagnostics Ltd	Dublin 11, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3019792804	MHC HEALTH MANAGEMENT SOLUTIONS, LLC	Cape Coral, FL, US
3031090645	IXLAYER	San Francisco, CA, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US
3026940910	SPOT HEALTH INC.	Cincinnati, OH, US
3020139194	LetsGetChecked Inc.	Cucamonga, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042854290. Last updated year: 2026. Please use registration number 3042854290 when referencing this establishment in official correspondence.