510(k) K132978

Device

IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST

Applicant

SEQUENOM, INC.

510(k) number

K132978

Product code

PHJ  

Decision

Substantially Equivalent (SESE)

Decision date

2014-06-13

Date received

2013-09-23

Regulation

864.7280

Classification name

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Medical specialty

Hematology

Review panel

Pathology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No