Medical Device Manufacturer · US , San Juan Capistrano , CA

Chroma Vision Medical Systems, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1999

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Chroma Vision Medical Systems, Inc. Pathology ✕

2 devices

1-2 of 2

Cleared Dec 23, 2003

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

Pathology · 167d

Cleared Sep 30, 2002

MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

Pathology · 447d