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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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