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FDA 510(k) Application Details - K163215
Device Classification Name
Whole Blood Hemoglobin Determination
More FDA Info for this Device
510(K) Number
K163215
Device Name
Whole Blood Hemoglobin Determination
Applicant
SANGUINA, LLC
575 14TH STREET
ATLANTA, GA 30318 US
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Contact
ERIKA TYBURSKI
Other 510(k) Applications for this Contact
Regulation Number
864.7500
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Classification Product Code
KHG
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More FDA Info for this Product Code
Date Received
11/16/2016
Decision Date
09/13/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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