The following data is part of a premarket notification filed by Amcor Electronics, Ltd. with the FDA for Karyotec 100.
| Device ID | K872755 |
| 510k Number | K872755 |
| Device Name: | KARYOTEC 100 |
| Classification | Analyzer, Chromosome, Automated |
| Applicant | AMCOR ELECTRONICS, LTD. SHENKAR ST., INDUSTRIAL ZONE Herzeliya, IL 46725 |
| Contact | Emanuel Mendes |
| Correspondent | Emanuel Mendes AMCOR ELECTRONICS, LTD. SHENKAR ST., INDUSTRIAL ZONE Herzeliya, IL 46725 |
| Product Code | LNJ |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-13 |
| Decision Date | 1987-09-01 |