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 |