FDA 510(k) Application Details - K102441

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K102441
Device Name	Immunoassay Method, Troponin Subunit
Applicant	NANO-DITECH CORPORATION 7 CLARKE DRIVE SUITE 3 CRANBURY, NJ 08512 US Other 510(k) Applications for this Company
Contact	YOUNG WOO KIM Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	MMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2010
Decision Date	10/20/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review