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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K031739
Device Name I-STAT CARDIAC TROPONIN (CTNI) TEST
Applicant
I-Stat Corporation
104 Windsor Center Dr.
East Windsor,  NJ  08520
Applicant Contact GREGORY W SHIPP
Correspondent
I-Stat Corporation
104 Windsor Center Dr.
East Windsor,  NJ  08520
Correspondent Contact GREGORY W SHIPP
Regulation Number862.1215
Classification Product Code
MMI  
Date Received06/04/2003
Decision Date 09/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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