NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY— 510(k) K101185

Name: FDA 510(k) clearance K101185
Creator: U.S. Food and Drug Administration
Published: 2011-09-20

Substantially Equivalent

Iris Molecular Diagnostics

FDA 510(k) clearance K101185 for NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY, Substantially Equivalent on 2011-09-20. Applicant: Iris Molecular Diagnostics. Device class: 2.

Clearance details

Applicant: Iris Molecular Diagnostics
Product code: Code OWM
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Date received: 2010-04-28
Decision date: 2011-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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