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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, natriuretic peptide
510(k) Number K053597
Device Name I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
Applicant
I-STAT CORPORATION
104 WINDSOR CENTER DRIVE
EAST WINDSOR,  NJ  08520
Applicant Contact SUE KENT
Correspondent
I-STAT CORPORATION
104 WINDSOR CENTER DRIVE
EAST WINDSOR,  NJ  08520
Correspondent Contact SUE KENT
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Code
JJX  
Date Received12/23/2005
Decision Date 07/21/2006
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
Recalls CDRH Recalls
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