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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, T Lymphocyte Surface Marker
510(k) Number K860830
Device Name TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact LEONARD A DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact LEONARD A DWARICA
Regulation Number864.5220
Classification Product Code
LIZ  
Date Received03/05/1986
Decision Date 09/08/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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