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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hematocrit
510(k) Number K021924
Device Name MEDICA EASYQC HEMATOCRIT CONTROL
Applicant
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01432
Applicant Contact KATHY STORRO
Correspondent
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01432
Correspondent Contact KATHY STORRO
Regulation Number864.8625
Classification Product Code
GLK  
Date Received06/11/2002
Decision Date 06/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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