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Access Bio, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
4
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAugust 22, 2025
K241915CareSuperb™ COVID-19 Antigen Home TestJanuary 29, 2025
K191514CareStart Flu A&B PlusFebruary 18, 2020