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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
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