The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Ariol Her-2/neu Fish.
| Device ID | K043519 |
| 510k Number | K043519 |
| Device Name: | ARIOL HER-2/NEU FISH |
| Classification | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays |
| Applicant | APPLIED IMAGING CORP. 120 BAYTECH DRIVE San Jose, CA 95134 -2302 |
| Contact | Diane C Day |
| Correspondent | Diane C Day APPLIED IMAGING CORP. 120 BAYTECH DRIVE San Jose, CA 95134 -2302 |
| Product Code | NTH |
| CFR Regulation Number | 866.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-04-25 |