Access Bio, Inc.

Medical device manufacturer in Monroe Township, NJ.

3510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestSCA · Traditional 08/22/2025SE
K241915CareSuperb™ COVID-19 Antigen Home TestQYT · Traditional 01/29/2025SE
K191514CareStart Flu A&B PlusPSZ · Dual Track 02/18/2020SE