The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Ariol Her-2/neu Ihc.
| Device ID | K031715 |
| 510k Number | K031715 |
| Device Name: | ARIOL HER-2/NEU IHC |
| Classification | Microscope, Automated, Image Analysis, Operator Intervention |
| Applicant | APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara, CA 95051 |
| Contact | Diane C Oates |
| Correspondent | Diane C Oates APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara, CA 95051 |
| Product Code | NOT |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2004-01-08 |