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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K013305
Device Name ENOXAPARIN TEST CARD
Applicant
Cardiovascular Diagnostics, Inc.
9401 Globe Center Dr.,Suite
140
Morrisville,  NC  27560
Applicant Contact PETER SCOTT
Correspondent
Cardiovascular Diagnostics, Inc.
9401 Globe Center Dr.,Suite
140
Morrisville,  NC  27560
Correspondent Contact PETER SCOTT
Regulation Number864.7525
Classification Product Code
KFF  
Date Received10/04/2001
Decision Date 08/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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