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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 K904461
Device Name METER TRAX
Applicant
Hematronix, Inc.
1505 Capital Ave.
Plano,  TX  75074
Applicant Contact JIM LAPICOLA
Correspondent
Hematronix, Inc.
1505 Capital Ave.
Plano,  TX  75074
Correspondent Contact JIM LAPICOLA
Regulation Number864.8625
Classification Product Code
JPK  
Date Received10/01/1990
Decision Date 10/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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