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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biosensor, Immunoassay, Cpk Or Isoenzymes
510(k) Number K051433
Device Name I-STAT CREATINE KINASE MB (CK-MB)
Applicant
I-Stat Corporation
104 Windsor Center Dr.
East Windsor,  NJ  08520
Applicant Contact SUE KENT
Correspondent
I-Stat Corporation
104 Windsor Center Dr.
East Windsor,  NJ  08520
Correspondent Contact SUE KENT
Regulation Number862.1215
Classification Product Code
MYT  
Subsequent Product Code
MMI  
Date Received06/01/2005
Decision Date 12/15/2005
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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