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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852643
Device Name UNI-PLATE
Applicant
Medical Specialties Laboratories
P.O.Box 659, Kenmore Station
Boston,  MA  02215
Applicant Contact JUDITH A BEATRICE
Correspondent
Medical Specialties Laboratories
P.O.Box 659, Kenmore Station
Boston,  MA  02215
Correspondent Contact JUDITH A BEATRICE
Date Received06/21/1985
Decision Date 08/08/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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