Home Access Health Corp.

Hoffman Est, IL, US

HOME ACCESS HEALTH CORP. appears in FDA device records in Hoffman Est, IL. FDA records list 2 510(k) clearances between 2007-11-09 and 2015-03-13, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Home Access Health Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Home Access Health Corp (HAHC)recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Home Access Health Corp. between 2007 and 2015. The busiest year on record is 2007, with 1. The most recent is 2015, with 1.

Clearances by year, as a table

510(k) clearance decisions for Home Access Health Corp., by decision year
Year	Clearances
2007	1
2015	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K141944	HOME ACCESS AIC TEST	LCP	Substantially Equivalent	2015-03-13
K063852	ACCESSA CHOLESTEROL PANEL	JKA	Substantially Equivalent	2007-11-09

Registered establishments

FDA registered establishments for Home Access Health Corp., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1423455	3000206414	HOME ACCESS HEALTH CORP.	2401 Hassell Rd Ste 1510, Hoffman Est, IL 60169 US	2026	CHH JGY JKA LBS LCP NNK OIB OOX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0150-2007	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 instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5	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.		2006-10-06	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain