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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 K844897
Device Name HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
Applicant
Medical Specialties Laboratories
P.O.Box 659, Kenmore Station
Boston,  MA  02215
Applicant Contact JUDITY A BEATRICE
Correspondent
Medical Specialties Laboratories
P.O.Box 659, Kenmore Station
Boston,  MA  02215
Correspondent Contact JUDITY A BEATRICE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received12/17/1984
Decision Date 03/22/1985
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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