HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT

Counter, Urine Particle

EKO SCANN AB

The following data is part of a premarket notification filed by Eko Scann Ab with the FDA for Hematology Computer-interface, Viscount.

Pre-market Notification Details

Device IDK822823
510k NumberK822823
Device Name:HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
ClassificationCounter, Urine Particle
Applicant EKO SCANN AB 803 N. Front St. Suite 3 McHenry,  IL  60050
Product CodeLKM  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-21
Decision Date1982-10-18

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