The following data is part of a premarket notification filed by Applied Spectral Imaging Ltd. with the FDA for Genasis Hipath Ihc Family.
| Device ID | K140957 |
| 510k Number | K140957 |
| Device Name: | GENASIS HIPATH IHC FAMILY |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | APPLIED SPECTRAL IMAGING LTD. P.O. BOX 4414 (A109) Caesarea, IL 30889 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon APPLIED SPECTRAL IMAGING LTD. P.O. BOX 4414 (A109) Caesarea, IL 30889 |
| Product Code | NQN |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2015-01-15 |
| Summary: | summary |