510(k) K101185

Device

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

Applicant

IRIS MOLECULAR DIAGNOSTICS

510(k) number

K101185

Product code

OWM  

Decision

Substantially Equivalent (SESE)

Decision date

2011-09-20

Date received

2010-04-28

Regulation

866.6040

Classification name

Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No