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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 K871067
Device Name MSI HEMATOLOGY CONTROL +
Applicant
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact RONALD DEVITA
Correspondent
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact RONALD DEVITA
Regulation Number864.8625
Classification Product Code
JPK  
Date Received03/18/1987
Decision Date 03/25/1987
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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