Data / Medical devices / United States / Home Access Health Corp.

Home Access Health Corp.: FDA-registered device maker in Hoffman Est, IL, United States, 3 510(k) clearances

Name: Home Access Health Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Home Access Health Corp. is registered with the FDA (registration 1423455) in Hoffman Est, IL, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 13, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1423455
FEI number: 3000206414
Address: 2401 Hassell Rd Ste 1510, Hoffman Est, IL, United States, 60169
Owner or operator: PWNHealth Chicago, LLC (9031348)
Roles: Manufacturer, Repackager or relabeler
First device listed: February 20, 2002
Registered through: 2026
Brand names listed: Home Collection, HomeAccess AiC, OC Auto Micro FOB, accessa cholesterol panel

Devices it lists

Device	Product code	Class	Role	Source
Assay, Glycosylated Hemoglobin	LCP	2	Manufacturer	accessdata.fda.gov
Automated Occult Blood Analyzer	OOX	2	Repackager or relabeler	accessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)	OIB	1	Manufacturer	accessdata.fda.gov
Colorimetric Method, Triglycerides	JGY	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Manufacturer	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 13, 2015	K141944	HOME ACCESS AIC TEST	LCP	Substantially Equivalent	Home Access Health Corp.	accessdata.fda.gov
November 9, 2007	K063852	ACCESSA CHOLESTEROL PANEL	JKA	Substantially Equivalent	Home Access Health Corp.	accessdata.fda.gov
October 21, 2004	K041408	POLYMEDCO OC AUTO MICRO 80 FOB TEST	OOX	Substantially Equivalent	Polymedco, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 6, 2006	36429	Not yet classified	Terminated	Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructi	Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.	accessdata.fda.gov

Compare with other makers

Updated March 13, 2015. 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.