The following data is part of a premarket notification filed by Chromavision Medical Systems, Inc. with the FDA for Modification To Acis (automated Cellular Imaging System).
| Device ID | K012138 |
| 510k Number | K012138 |
| Device Name: | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | CHROMAVISION MEDICAL SYSTEMS, INC. 33171 PASEO CERVEZA San Juan Capestrano, CA 92675 |
| Contact | David Davis |
| Correspondent | David Davis CHROMAVISION MEDICAL SYSTEMS, INC. 33171 PASEO CERVEZA San Juan Capestrano, CA 92675 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-10 |
| Decision Date | 2002-09-30 |