510(k) K984188

AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) by Chroma Vision Medical Systems, Inc. — Product Code JOY

K984188 is an FDA 510(k) premarket notification submitted by Chroma Vision Medical Systems, Inc. for the device "AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)". The FDA issued a decision of Substantially Equivalent on July 28, 1999. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Chroma Vision Medical Systems, Inc. has at least 2 other 510(k) clearances on record.