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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, factor v leiden mutations, genomic dna pcr
510(k) Number K100980
Device Name INVADER FACTOR V
Applicant
HOLOGIC, INC.
250 CAMPUS DRIVE
marlborough,  MA  01752
Applicant Contact randall j covill
Correspondent
HOLOGIC, INC.
250 CAMPUS DRIVE
marlborough,  MA  01752
Correspondent Contact randall j covill
Regulation Number864.7280
Classification Product Code
NPQ  
Date Received04/08/2010
Decision Date 06/01/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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