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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 K102131
Device Name NANO-CHECK AMI CTNI CARDIAC MARKER TEST
Applicant
NANO-DITECH CORPORATION
7 CLARKE DRIVE
SUITE 3
CRANBURY,  NJ  08512
Applicant Contact YOUNG HOON KIM
Correspondent
NANO-DITECH CORPORATION
7 CLARKE DRIVE
SUITE 3
CRANBURY,  NJ  08512
Correspondent Contact YOUNG HOON KIM
Regulation Number862.1215
Classification Product Code
MMI  
Date Received07/29/2010
Decision Date 10/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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