The following data is part of a premarket notification filed by Eko Scann Ab with the FDA for Hematology Computer-interface, Viscount.
| Device ID | K822823 |
| 510k Number | K822823 |
| Device Name: | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT |
| Classification | Counter, Urine Particle |
| Applicant | EKO SCANN AB 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-21 |
| Decision Date | 1982-10-18 |