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FDA 510(k) Application Details - K180762
Device Classification Name
Abnormal Hemoglobin Quantitation
More FDA Info for this Device
510(K) Number
K180762
Device Name
Abnormal Hemoglobin Quantitation
Applicant
SEBIA
1705 Corporate Drive, Suite 400
Norcross, GA 30093 US
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Contact
Karen Anderson
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Regulation Number
864.7415
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Classification Product Code
GKA
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More FDA Info for this Product Code
Date Received
03/23/2018
Decision Date
12/14/2018
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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