ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING— 510(k) K093974

Name: FDA 510(k) clearance K093974
Creator: U.S. Food and Drug Administration
Published: 2010-04-22

Substantially Equivalent

Osmetech Molecular Diagnostics

FDA 510(k) clearance K093974 for ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING, Substantially Equivalent on 2010-04-22. Applicant: Osmetech Molecular Diagnostics. Device class: 2.

Clearance details

Applicant: Osmetech Molecular Diagnostics
Product code: Code NPQ
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Date received: 2009-12-23
Decision date: 2010-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPQ

view all

K100980 — INVADER FACTOR V2011-06-01
K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II2010-04-28
K082118 — XPERT HEMOSIL FACTOR II & FACTOR V ASSAY2009-09-18
K060564 — INFINITI SYSTEM2007-02-07
DEN030005 — FACTOR V LEIDEN KIT2003-12-17

More clearances from Osmetech Molecular Diagnostics

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.