ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II— 510(k) K093129

Name: FDA 510(k) clearance K093129
Creator: U.S. Food and Drug Administration
Published: 2010-04-28

Substantially Equivalent

Illumina, Inc.

FDA 510(k) clearance K093129 for ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II, Substantially Equivalent on 2010-04-28. Applicant: Illumina, Inc.. Device class: 2.

Clearance details

Applicant: Illumina, Inc.
Product code: Code NPQ
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Date received: 2009-10-02
Decision date: 2010-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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