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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr
510(k) Number K100987
Device Name INVADER MTHFR 677
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
OMM  
Date Received04/09/2010
Decision Date 05/13/2011
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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