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510(k) K033612

Device
FACTOR II (PROTHROMBIN) G20210A KIT
Applicant
ROCHE DIAGNOSTICS CORP.
510(k) number
K033612
Product code
NPR  
Decision
Substantially Equivalent (SESE)
Decision date
2003-12-18
Date received
2003-11-17
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
ROBERT A GREGG
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

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
K100943INVADER FACTOR IIHologic, Inc.2011-06-02

Legacy Summary#

summary

FDA Review#

Decision Summary