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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
Contact randall j covill
Regulation Number864.7280
Classification Product Code
NPQ  
Date Received04/08/2010
Decision Date 06/01/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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