Data / Medical devices / United States / Mandarin Enterprises, LLC

Mandarin Enterprises, LLC: FDA-registered device maker in Atlanta, GA, United States, 7 510(k) clearances

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

Mandarin Enterprises, LLC is registered with the FDA (registration 3007154442) in Atlanta, GA, United States. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 10, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007154442
Address: 2625 Piedmont RD Ne Ste 56-129, Atlanta, GA, United States, 30324
Owner or operator: Mandarin Enterprises, LLC (10024035)
Roles: Repackager or relabeler
First device listed: September 11, 2015
Registered through: 2026
Brand names listed: Clinical Guard, Mandarin Enterprises LLC

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Repackager or relabeler	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Repackager or relabeler	accessdata.fda.gov
Oximeter, Wellness	PGJ	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	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
April 10, 2013	K123703	HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)	LCX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
August 10, 2012	K120554	ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
July 28, 2011	K103574	PREGNANCY ONE STEP RAPID TEST	LCX	Substantially Equivalent	Lehnus & Associates Consulting	accessdata.fda.gov
September 17, 2008	K081738	ULTRASONIC NEBULIZER SYSTEM, MODEL HL100	CAF	Substantially Equivalent	Health & Life Co., Ltd.	accessdata.fda.gov
November 1, 2007	K072641	DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.	FLL	Substantially Equivalent	Famidoc Technology Co., Ltd.	accessdata.fda.gov
February 6, 2006	K051699	SEJOY, MODEL MT-403	FLL	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
October 26, 2005	K052849	INFRARED THERMOMETER, FDIR-V1	FLL	Substantially Equivalent	Famidoc Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 10, 2013. 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.