Medical Device Manufacturer · US , Sharon , MA

Boston Cell Standards, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2022

Recent clearances: Her-2, ER, PR IHControls

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Boston Cell Standards, Inc. Pathology ✕

1 devices

1-1 of 1

Cleared Aug 15, 2022

Her-2, ER, PR IHControls

Pathology · 207d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: May 21, 2026