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FDA 510(k) Application Details - K183680
Device Classification Name
Device, Hematocrit Measuring
More FDA Info for this Device
510(K) Number
K183680
Device Name
Device, Hematocrit Measuring
Applicant
Abbott Point of Care Inc.
400 College Road East
Princeton, NJ 08540 US
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Contact
Susan Tibedo
Other 510(k) Applications for this Contact
Regulation Number
864.6400
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Classification Product Code
JPI
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More FDA Info for this Product Code
Date Received
12/28/2018
Decision Date
02/28/2020
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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