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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name system, hemoglobin, automated
510(k) Number BK200520
Tradenames DiaSpect Tm, DiaSpect Tm Cuvettes, DiaSpect TM System, DiaSpectTM syster
Device Name System, Hemoglobin, Automated
Original Applicant
EKF-diagnostic GmbH
ebendorfer chaussee 3
Barleben,  39179,  GERMANY
Regulation Number864.5620
Classification Product Code
GKR  
Date Received09/10/2020
Decision Date 11/24/2020
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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