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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 K992571
Device Name I-STAT SYSTEM
Applicant
I-STAT CORP.
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08520
Applicant Contact PAUL VANDERWERF
Correspondent
I-STAT CORP.
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08520
Correspondent Contact PAUL VANDERWERF
Regulation Number864.7140
Classification Product Code
JBP  
Date Received08/02/1999
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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