FDA.reportPublic FDA data

Access Bio, Inc.

Matched from indexed company URL: Access Bio Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30247566653024756665Access Bio, Inc.1N2026-01-017 Fitzgerald Ave Monroe Township NJ US 08831
30039663683008474767ACCESS BIO INCORPORATE1Y2020-04-2565 Clyde Rd Ste A Somerset NJ US 08873

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3102521399528652K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestSCA2025-08-22
3102522055607328K241915CareSuperb™ COVID-19 Antigen Home TestQYT2025-01-29
980261351714554
980261416333587
980261537185909
980261826780847
980261851304182
980261890369568
980261906770399
3102521061750371
3102521273170653
3102521351714554
3102521414620313
3102521416344332
3102521754264603
3102521851304182

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SCA12025-08-22
QYT12025-01-29

PMN#

GUDID#