Cleared Traditional

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING

K093974 · Osmetech Molecular Diagnostics · Pathology
Apr 2010
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K093974 is an FDA 510(k) clearance for the ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING, a Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPQ), submitted by Osmetech Molecular Diagnostics (Pasadena, US). The FDA issued a Cleared decision on April 22, 2010, 120 days after receiving the submission on December 23, 2009. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number K093974 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2009
Decision Date April 22, 2010
Days to Decision 120 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7280
Definition In Vitro Diagnostic Test To Detect The Factor V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.