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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 K834043
Device Name MSI-HC HEMATOLOGY CONTROL
Applicant
MEDICAL SPECIALTIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDICAL SPECIALTIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.8625
Classification Product Code
JPK  
Date Received11/23/1983
Decision Date 01/03/1984
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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