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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 K943283
Device Name HEPARIN MANAGEMENT TEST CARD; HMT CARD
Applicant
Cardiovascular Diagnostics, Inc.
5301 Departure Dr.
Raleigh,  NC  27616
Applicant Contact DIANE N PEPER
Correspondent
Cardiovascular Diagnostics, Inc.
5301 Departure Dr.
Raleigh,  NC  27616
Correspondent Contact DIANE N PEPER
Regulation Number864.7525
Classification Product Code
KFF  
Date Received07/07/1994
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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