MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)— 510(k) K012138

Substantially Equivalent

Chroma Vision Medical Systems, Inc.

FDA 510(k) clearance K012138 for MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM), Substantially Equivalent on 2002-09-30. Applicant: Chroma Vision Medical Systems, Inc..

Clearance details

Applicant: Chroma Vision Medical Systems, Inc.
Product code: Code MYA
Advisory panel: Hematology
Date received: 2001-07-10
Decision date: 2002-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.