FDA.reportPublic FDA data

HOME ACCESS HEALTH CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14234553000206414HOME ACCESS HEALTH CORP.1N2026-01-012401 Hassell Rd Ste 1510 Hoffman Est IL US 60169

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M769HCV271Hepatitis C Check - The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HCV (Hepatitis C) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing.847-781-2503mvogt@homeaccess.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
538271816319220P980046HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESSQRO1999-04-28
538271671897209K141944HOME ACCESS AIC TESTLCP2015-03-13
538271332973523K063852ACCESSA CHOLESTEROL PANELJKA2007-11-09
538271961885456K041408POLYMEDCO OC AUTO MICRO 80 FOB TESTOOX2004-10-21
538271270247095BP950002
538271182855157
538271599665345
538272055766438

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCP22015-03-13
JKA22007-11-09
OOX22004-10-21
MZO11999-04-28

PMA#

PMN#

GUDID#

Express HIV-1 Test System - The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.

Home Access Health Corporation

2015-09-03

HIV-1 Standard Test System - The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.

Home Access Health Corporation

2015-09-03