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510(k) K102131

NANO-CHECK AMI CTNI CARDIAC MARKER TEST by Nano-Ditech Corporation — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2010
Date Received
July 29, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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