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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 ii g20210a mutations, genomic dna pcr
510(k) Number K100943
Device Name INVADER FACTOR II
Applicant
HOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH,  MA  01752
Applicant Contact RANDALL COVILL
Correspondent
HOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH,  MA  01752
Correspondent Contact RANDALL COVILL
Regulation Number864.7280
Classification Product Code
NPR  
Date Received04/06/2010
Decision Date 06/02/2011
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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