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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 K812357
Device Name VENTREX DATA REDUCTION & QUAL. CONTR. SY
Applicant
VENTREX LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VENTREX LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.8625
Classification Product Code
JPK  
Date Received08/20/1981
Decision Date 09/01/1981
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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