IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST— 510(k) K132978

Name: FDA 510(k) clearance K132978
Creator: U.S. Food and Drug Administration
Published: 2014-06-13

Substantially Equivalent

Sequenom, Inc.

FDA 510(k) clearance K132978 for IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST, Substantially Equivalent on 2014-06-13. Applicant: Sequenom, Inc.. Device class: 2.

Clearance details

Applicant: Sequenom, Inc.
Product code: Code PHJ
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Date received: 2013-09-23
Decision date: 2014-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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