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FDA 510(k) Application Details - K220031
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K220031
Device Name
Counter, Differential Cell
Applicant
Abbott Laboratories
4551 Great America Pkwy
Santa Clara, CA 95054 US
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Contact
Neha Vatsyayan
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Regulation Number
864.5220
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Classification Product Code
GKZ
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More FDA Info for this Product Code
Date Received
01/05/2022
Decision Date
08/04/2023
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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