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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name quality control material, genetics, dna
510(k) Number K093737
Device Name HEMOSIL F11 & FV DNA CONTROL
Applicant
INSTRUMENTATION LABORATORY CO.
180 BEDFORD ROAD
bedford,  MA  01730
Applicant Contact carol marble
Correspondent
INSTRUMENTATION LABORATORY CO.
180 BEDFORD ROAD
bedford,  MA  01730
Correspondent Contact carol marble
Regulation Number866.5910
Classification Product Code
NZB  
Date Received12/04/2009
Decision Date 05/04/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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