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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 K820401
Device Name ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
Applicant
Orhto Diagnostic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Orhto Diagnostic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.8625
Classification Product Code
JPK  
Date Received02/12/1982
Decision Date 03/15/1982
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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