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510(k) K163342

i-STAT Hematocrit test with i-STAT Alinity System by Abbott Laboratories — Product Code JPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2017
Date Received
November 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Hematocrit Measuring
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type

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