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FDA 510(k) Application Details - K100980
Device Classification Name
Test, Factor V Leiden Mutations, Genomic Dna Pcr
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510(K) Number
K100980
Device Name
Test, Factor V Leiden Mutations, Genomic Dna Pcr
Applicant
HOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH, MA 01752 US
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Contact
RANDALL J COVILL
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Regulation Number
864.7280
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Classification Product Code
NPQ
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More FDA Info for this Product Code
Date Received
04/08/2010
Decision Date
06/01/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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