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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 K100496
Device Name INVADER MTHFR 1298
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
OMM  
Date Received02/22/2010
Decision Date 04/25/2011
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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