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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K935343
Device Name CENTRIFIQ BLOOD CONTROL
Applicant
Hematronix, Inc.
1505 Capital Ave.
Plano,  TX  75074
Applicant Contact JAMES D LAPICOLA
Correspondent
Hematronix, Inc.
1505 Capital Ave.
Plano,  TX  75074
Correspondent Contact JAMES D LAPICOLA
Regulation Number864.8625
Classification Product Code
JPK  
Date Received09/21/1993
Decision Date 01/27/1994
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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