The following data is part of a premarket notification filed by Bioimagene, Inc. with the FDA for Pathiam System For Her2/neu Immunohistochemistry Reagents & Kits.
| Device ID | K080910 |
| 510k Number | K080910 |
| Device Name: | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS |
| Classification | Microscope, Automated, Image Analysis, Operator Intervention |
| Applicant | BIOIMAGENE, INC. 1601 S. DE ANZA BLVD SUITE 212 Cupertino, CA 95014 |
| Contact | Indu Lakshman |
| Correspondent | Indu Lakshman BIOIMAGENE, INC. 1601 S. DE ANZA BLVD SUITE 212 Cupertino, CA 95014 |
| Product Code | NOT |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-01 |
| Decision Date | 2009-02-04 |
| Summary: | summary |