Data / Medical devices / United States / Lake County Press

Lake County Press: FDA-registered device maker in Waukegan, IL, United States, 6 510(k) clearances

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

Lake County Press is registered with the FDA (registration 3009901017) in Waukegan, IL, United States. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 5, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009901017
Address: 3210 Oak Grove Avenue Suite B, Waukegan, IL, United States, 60087
Owner or operator: Lake County Press (10083143)
Roles: Repackager or relabeler
First device listed: December 4, 2025
Registered through: 2026
Brand names listed: ADHESIVE BANDAGES, Dexcom G6, Dexcom G7, Dexcom Stelo, Medline Blood Pressure Monitor, Omron 7450 Blood Pressure Monitor, TaiDoc Ketone Meter

Devices it lists

Device	Product code	Class	Role	Source
Glucose Dehydrogenase, Glucose	LFR	2	Repackager or relabeler	accessdata.fda.gov
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter	SAF	2	Repackager or relabeler	accessdata.fda.gov
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management	QDK	2	Repackager or relabeler	accessdata.fda.gov
Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use	QII	2	Repackager or relabeler	accessdata.fda.gov
Integrated Continuous Glucose Monitoring System, Factory Calibrated	QBJ	2	Repackager or relabeler	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	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
March 5, 2024	K234070	Stelo Glucose Biosensor System	SAF	Substantially Equivalent	Dexcom, Inc.	accessdata.fda.gov
May 15, 2023	K231081	Dexcom G7 Continuous Glucose Monitoring (CGM) System	QBJ	Substantially Equivalent	Dexcom, Inc.	accessdata.fda.gov
July 29, 2022	K221259	Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System	QBJ	Substantially Equivalent	Dexcom, Inc.	accessdata.fda.gov
July 12, 2020	K193627	Automatic Upper Arm Blood Pressure Monitor	DXN	Substantially Equivalent	Dongguan E-Test Technology Co., Ltd.	accessdata.fda.gov
November 10, 2016	K161738	FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems	NBW	Substantially Equivalent	Taidoc Technology Corporation	accessdata.fda.gov
September 8, 2005	K052154	OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC	DXN	Substantially Equivalent	Omron Healthcare, Inc.	accessdata.fda.gov

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Updated March 5, 2024. 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.