BK200520 – DiaSpect system
Anonymous (not verified)
Fri, 11/20/2020 – 14:30
Detailed Description
The DiaSpect system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2-EDTA or lithium heparin tubes in point-of-care settings
510(k) Number: BK200520
Applicant: EKF-diagnostic GmbH
Device Name: DiaSpectTM system
Decision Date: 11/19/2020
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BK200520 – DiaSpect system
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BK200520-Letter.pdf34.61 KB
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BK200520 Letter
BK200520-Summary.pdf107.42 KB
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BK200520 Summary
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