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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 K102441
Device Name NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
Applicant
NANO-DITECH CORPORATION
7 CLARKE DRIVE
SUITE 3
CRANBURY,  NJ  08512
Applicant Contact YOUNG WOO KIM
Correspondent
NANO-DITECH CORPORATION
7 CLARKE DRIVE
SUITE 3
CRANBURY,  NJ  08512
Correspondent Contact YOUNG WOO KIM
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
DDR  
Date Received07/29/2010
Decision Date 10/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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