EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

System, Hemoglobin, Automated

EKF-DIAGNOSTIC GMBH

The following data is part of a premarket notification filed by Ekf-diagnostic Gmbh with the FDA for Ekf- Diagnostic Hemo_control Hemoglobin Measurement System; Ekf-diagnostic Hemoglobin Microcuvettes (modified Curvette W.

Pre-market Notification Details

Device IDK110393
510k NumberK110393
Device Name:EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
ClassificationSystem, Hemoglobin, Automated
Applicant EKF-DIAGNOSTIC GMBH S65 W35739 PIPER ROAD Eagle,  WI  53119
ContactStephen Gorski
CorrespondentStephen Gorski
EKF-DIAGNOSTIC GMBH S65 W35739 PIPER ROAD Eagle,  WI  53119
Product CodeGKR  
CFR Regulation Number864.5620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-11
Decision Date2011-03-04
Summary:summary

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