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510(k) K100943

Device
INVADER FACTOR II
Applicant
HOLOGIC, INC.
510(k) number
K100943
Product code
NPR  
Decision
Substantially Equivalent (SESE)
Decision date
2011-06-02
Date received
2010-04-06
Regulation
864.7280
Classification name
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Medical specialty
Hematology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RANDALL COVILL
Address
250 Campus Dr. Malborough MA US 01752 01752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NPR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250218Xpert® FII & FVCepheid2025-02-21
K223046Xpert® FII & FVCepheid®2023-02-15
K172913cobas Factor II and Factor V TestRoche Molecular Systems, Inc.2018-01-12
K033612FACTOR II (PROTHROMBIN) G20210A KITRoche Diagnostics Corp.2003-12-18

Legacy Summary#

summary

FDA Review#

Decision Summary