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510(k) K013062

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT by Biocheck, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2002
Date Received
September 12, 2001
Clearance Type
Traditional
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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