510(k) K012138

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

K012138 is an FDA 510(k) premarket notification submitted by Chroma Vision Medical Systems, Inc. for the device "MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)". The FDA issued a decision of Substantially Equivalent on September 30, 2002. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Chroma Vision Medical Systems, Inc. has at least 2 other 510(k) clearances on record.