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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
Recalls CDRH Recalls
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