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 |
UK SUNNYHEART LIMITED 2024-07-16 |