The following data is part of a premarket notification filed by Applied Spectral Imaging, Ltd. with the FDA for Fishview.
| Device ID | K050236 |
| 510k Number | K050236 |
| Device Name: | FISHVIEW |
| Classification | Analyzer, Chromosome, Automated |
| Applicant | APPLIED SPECTRAL IMAGING, LTD. 6 SIRENI ST. Haifa, IL 32972 |
| Contact | Dan Laor |
| Correspondent | Dan Laor APPLIED SPECTRAL IMAGING, LTD. 6 SIRENI ST. Haifa, IL 32972 |
| Product Code | LNJ |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-31 |
| Decision Date | 2005-06-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FISHVIEW 98651643 not registered Live/Pending |
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