INVADER FACTOR II

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Invader Factor Ii.

Pre-market Notification Details

Device IDK100943
510k NumberK100943
Device Name:INVADER FACTOR II
ClassificationTest, Factor Ii G20210a Mutations, Genomic Dna Pcr
Applicant HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
ContactRandall Covill
CorrespondentRandall Covill
HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
Product CodeNPR  
CFR Regulation Number864.7280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-06
Decision Date2011-06-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506701 K100943 000
15420045506664 K100943 000

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