ARIOL
Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
APPLIED IMAGING CORP.
The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Ariol.
Pre-market Notification Details
| Device ID | K033200 |
| 510k Number | K033200 |
| Device Name: | ARIOL |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara, CA 95051 |
| Contact | Diane Oates |
| Correspondent | Diane Oates APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara, CA 95051 |
| Product Code | NQN |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-02 |
| Decision Date | 2004-03-18 |
Trademark Results [ARIOL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARIOL 76394535 2784850 Live/Registered |
LEICA BIOSYSTEMS IMAGING INC. 2002-04-11 |
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