The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Genevision - Computer Assisted Chromosome Karyo..
| Device ID | K902311 |
| 510k Number | K902311 |
| Device Name: | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. |
| Classification | Analyzer, Chromosome, Automated |
| Applicant | APPLIED IMAGING CORP. 2340A WALSH AVE. Santa Clara, CA 95051 |
| Contact | Stephen M Rudy |
| Correspondent | Stephen M Rudy APPLIED IMAGING CORP. 2340A WALSH AVE. Santa Clara, CA 95051 |
| Product Code | LNJ |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-23 |
| Decision Date | 1990-08-20 |