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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 K013062
Device Name BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
Applicant
Biocheck, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Applicant Contact ROBIN J HELLEN
Correspondent
Biocheck, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Correspondent Contact ROBIN J HELLEN
Regulation Number862.1215
Classification Product Code
MMI  
Date Received09/12/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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