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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K020355
Device Name I-STAT PROTHROMBIN TIME TEST
Applicant
I-Stat Corporation
104 Windsor Center Dr.
East Windsor,  NJ  08540
Applicant Contact PAUL VANDERERF
Correspondent
I-Stat Corporation
104 Windsor Center Dr.
East Windsor,  NJ  08540
Correspondent Contact PAUL VANDERERF
Regulation Number864.7750
Classification Product Code
GJS  
Date Received02/04/2002
Decision Date 05/14/2002
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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