Medical Device Manufacturer · US , Beverly , MA

Hamilton Thorne Biosciences - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2004

3

Total

2

Cleared

1

Denied

FDA 510(k) Regulatory Record - Hamilton Thorne Biosciences Obstetrics & Gynecology ✕

3 devices

1-3 of 3

Cleared Apr 24, 2007

Obstetrics & Gynecology · 138d

Cleared Apr 28, 2005

ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4

Obstetrics & Gynecology · 34d

Not Cleared Nov 04, 2004

HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)

DEN040009 · MRX

Obstetrics & Gynecology · 71d