Data / Medical devices / United States / LetsGetChecked Inc

LetsGetChecked Inc: FDA-registered device maker in City View Heights, OH, United States, 5 510(k) clearances

Name: LetsGetChecked Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

LetsGetChecked Inc is registered with the FDA (registration 3042854290) in City View Heights, OH, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch LetsGetChecked Inc

FDA registration number: 3042854290
Address: Suite 300, 8407 Firebird Dr, Fairfield, OH 45011, USA, City View Heights, OH, United States, 45011
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 ImPress, LetsGetChecked Saliva Sample Collection Kit, LetsGetChecked Stool Sample Collection Kit, LetsGetChecked Swab Sample Collection Kit, LetsGetChecked Urine Sample Collection Kit and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Complaint file establishment	accessdata.fda.gov
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
Dna Specimen Collection, Saliva	OYJ	2	Complaint file establishment	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	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
January 13, 2025	K242680	LetsGetChecked Impress	FMK	Unknown	Privapath Diagnostics Ltd (Dba Letsgetchecked)	accessdata.fda.gov
November 15, 2023	DEN200070	Simple 2 Test	QYA	Unknown	Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)	accessdata.fda.gov
October 27, 2022	K212745	ORAcollect®Dx	OYJ	Substantially Equivalent	DNA Genotek, Inc.	accessdata.fda.gov
February 19, 2015	K141410	ORAGENE DX OGD-500.001	OYJ	Substantially Equivalent	DNA Genotek, Inc.	accessdata.fda.gov

Compare with other makers

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.