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510(k) K023582

I-STAT KAOLIN ACT TEST by I-Stat Corporation — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2003
Date Received
October 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

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