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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name activated whole blood clotting time
510(k) Number K023582
Device Name I-STAT KAOLIN ACT TEST
Applicant
I-STAT CORPORATION
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08520
Applicant Contact PAUL VANDERWERF
Correspondent
I-STAT CORPORATION
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08520
Correspondent Contact PAUL VANDERWERF
Regulation Number864.7140
Classification Product Code
JBP  
Date Received10/24/2002
Decision Date 09/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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