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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K172173
Device Name DiaSpect Tm, DiaSpect Tm Cuvettes
Applicant
Ekf-Diagnostic GmbH
Ebendorfer Chaussee 3
Barleben,  DE 39179
Applicant Contact Mick Fenton
Correspondent
Ekf-Diagnostic GmbH
Ebendorfer Chaussee 3
Barleben,  DE 39179
Correspondent Contact Mick Fenton
Regulation Number864.5620
Classification Product Code
GKR  
Date Received07/19/2017
Decision Date 04/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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