Medical Device Manufacturer · US , Somerset , NJ

Access Bio, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Access Bio, Inc. Microbiology ✕
3 devices
1-3 of 3
Cleared Aug 22, 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · SCA
Microbiology · 87d
Cleared Jan 29, 2025
CareSuperb™ COVID-19 Antigen Home Test
K241915 · QYT
Microbiology · 212d
Cleared Feb 18, 2020
CareStart Flu A&B Plus
K191514 · PSZ
Microbiology · 256d
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