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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 K850250
Device Name TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact DWARICA
Regulation Number864.8625
Classification Product Code
JPK  
Date Received01/22/1985
Decision Date 04/01/1985
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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